Remote health monitoring and maintenance system

ABSTRACT

A system and method is described that enables a health care provider to monitor and manage a health condition of a patient. The system includes a health care provider apparatus operated by a health care provider and a remotely programmable patient apparatus that is operated by a patient. The health care provider develops a script program using the health care provider apparatus and then sends the script program to a remotely programmable patient apparatus through a communication network such as the World Wide Web. The script program is a computer-executable patient protocol that provides information to the patient about the patient&#39;s health condition and that interactively monitors the patient health condition by asking the patient questions and by receiving answers to those questions. The answers to these health related questions are then forwarded as patient data from the remotely programmable patient apparatus to the health care provider apparatus through the communication network. The patient data may also include information supplied by a physiological monitoring device such as a blood glucose monitor that is connected to the remotely programmable patient apparatus. When the patient data arrives at the health care provider apparatus, the patient data is processed for further management of the patient&#39;s health condition by the health care provider, such as forwarding another script program to the remotely programmable patient apparatus.

RELATED APPLICATIONS

This is a continuing application claiming the priority of the followingapplications:

-   (1) application Ser. No. 08/481,925, filed Jun. 7, 1995, which is a    FWC of application Ser. No. 08/233,397, filed Apr. 26, 1994 (now    abandoned), which in turn is a continuation-in-part of application    Ser. No. 07/977,323, filed Nov. 17, 1992 (which has since issued as    U.S. Pat. No. 5,307,263); and-   (2) application Ser. No. 08/946,341, filed Oct. 7, 1997, which    claims priority from provisional application Ser. No. 60/041,746    filed Mar. 28, 1997 and from provisional application Ser. No.    60/041,751 filed Mar. 28, 1997;    all of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to remote health monitoring andmaintenance system that enables a bi-directional interaction between apatient and a health care provider regarding a health care conditionassociated with the patient, the bi-directional interaction employing ahealth care provider apparatus and a remotely programmable patientapparatus.

BACKGROUND OF THE INVENTION

Controlling or curing conditions of ill health generally involves bothestablishing a therapeutic program and monitoring the progress of theafflicted person. Based on that progress, decisions can be made as toaltering therapy to achieve a cure or maintain the affliction orcondition at a controlled level. Successfully treating certain healthconditions calls for rather frequent monitoring and a relatively highdegree of patient participation. For example, in order to establish andmaintain a regimen for successful diabetes care, a diabetic shouldmonitor his or her blood glucose level and record that information alongwith the date and time at which the monitoring took place. Since diet,exercise, and medication all affect blood glucose levels, a diabeticoften must record data relating to those items of information along withblood glucose level so that the diabetic may more closely monitor his orher condition and, in addition, can provide information of value to thehealthcare provider in determining both progress of the patient anddetecting any need to change the patient's therapy program.

Advances in the field of electronics over the past several years havebrought about significant changes in medical diagnostic and monitoringequipment, including arrangements for self-care monitoring of variouschronic conditions. With respect to the control and monitoring ofdiabetes, relatively inexpensive and relatively easy-to-use bloodglucose monitoring systems have become available that provide reliableinformation that allows a diabetic and his or her healthcareprofessional to establish, monitor and adjust a treatment plan (diet,exercise, and medication). More specifically, microprocessor-based bloodglucose monitoring systems are being marketed which sense the glucoselevel of a blood sample that is applied to a reagent-impregnated regionof a test strip that is inserted in the glucose monitor. When themonitoring sequence is complete, the blood glucose level is displayedby, for example, a liquid crystal display (LCD) unit.

Typically, currently available self-care blood glucose monitoring unitsinclude a calendar/clock circuit and a memory circuit that allows anumber of blood glucose test results to be stored along with the dateand time at which the monitoring occurred. The stored test results(blood glucose level and associated time and date) can be sequentiallyrecalled for review by the blood glucose monitor user or a healthprofessional by sequentially actuating a push button or other controlprovided on the monitor. In some commercially available devices, theaverage of the blood glucose results that are stored in the monitor (orthe average of the results for a predetermined period of time, e.g.,fourteen days) also is displayed during the recall sequence. Further,some self-care blood glucose monitors allow the user to tag the testresult with an “event code” that can be used to organize the testresults into categories. For example, a user might use a specific eventcode to identify test results obtained at particular times of the day, adifferent event code to identify a blood glucose reading obtained aftera period of exercise, two additional event codes to identify bloodglucose readings taken during hypoglycemia symptoms and hyperglycemiasymptoms, etc. When event codes are provided and used, the event codetypically is displayed with each recalled blood glucose test result.

Microprocessor-based blood glucose monitoring systems have advantagesother than the capability of obtaining reliable blood glucose testresults and storing a number of the results for later recall and review.By using low power microprocessor and memory circuits and powering theunits with small, high capacity batteries (e.g., a single alkalinebattery), extremely compact and light designs have been achieved thatallow taking the blood glucose monitoring system to work, school, oranywhere else the user might go with people encountered by the user notbecoming aware of the monitoring system. In addition, mostmicroprocessor-based self-care blood glucose monitoring systems have amemory capacity that allows the system to be programmed by themanufacturer so that the monitor displays a sequence of instructionsduring any necessary calibration or system tests and during the bloodglucose test sequence itself. In addition, the system monitors varioussystem conditions during a blood glucose test (e.g., whether a teststrip is properly inserted in the monitor and whether a sufficientamount of blood has been applied to the reagent impregnated portion ofthe strip) and if an error is detected generates an appropriate display(e.g., “retest”). A data port may be provided that allows test resultsstored in the memory of the microprocessor-based blood glucosemonitoring system to be transferred to a data port (e.g., RS-232connection) of a personal computer or other such device for subsequentanalysis.

Microprocessor-based blood glucose monitoring systems are a significantadvance over previously available self-care systems such as thoserequiring a diabetic to apply a blood sample to reagent activatedportions of a test strip; wipe the blood sample from the test stripafter a predetermined period of time; and, after a second predeterminedperiod of time, determine blood glucose level by comparing the color ofthe reagent activated regions of the test strip with a color chartsupplied by the test strip manufacturer. Despite what has been achieved,numerous drawbacks and disadvantages still exist. For example,establishing and maintaining diabetic healthcare often requires thediabetic to record additional data pertaining to medication, foodintake, and exercise. However, the event codes of currently availablemicroprocessor blood glucose monitoring systems provide only limitedcapability for tagging and tracking blood glucose test results accordingto food intake and other relevant factors. For example, the event codesof currently available monitoring systems only allow the user toclassify stored blood glucose readings in a manner that indicates bloodglucose tests taken immediately after a heavy, light or normal meal.This method of recording information not only requires subjectivejudgment by the system user, but will not suffice in a situation inwhich successfully controlling the user's diabetes requires therecording and tracking of relatively accurate information relating tofood intake, exercise, or medication (e.g., insulin dosage). Anotherwise significant advantage of currently available blood glucosemonitoring systems is lost when blood glucose test results must berecorded and tracked with quantitative information relating tomedication, food intake, or exercise. Specifically, the system user mustrecord the required information along with a time and date tagged bloodglucose test result by, for example, writing the information in a logbook.

The use of event codes to establish subcategories of blood glucose testresults has an additional disadvantage or drawback. In particular,although alphanumeric display devices are typically used in currentlyavailable microprocessor-based blood glucose monitoring systems, thedisplay units are limited to a single line of information having on theorder of six characters. Moreover, since the systems include noprovision for the user to enter alphanumeric information, any eventcodes that are used must be indicated on the display in a genericmanner, e.g., displayed as “EVENT 1”, “EVENT 2”, etc. This limitationmakes the system more difficult to use because the diabetic must eithermemorize his or her assignment of event codes or maintain a list thatdefines the event codes. The limited amount of data that can bedisplayed at any one time presents additional drawbacks anddisadvantages. First, instructions and diagnostics that are displayed tothe user when calibrating the system and using the system to obtain ablood glucose reading must be displayed a line at a time and in manycases, the information must be displayed in a cryptic manner.

The above-discussed display limitations and other aspects of currentlyavailable blood glucose monitoring systems is disadvantageous in yetanother way. Little statistical information can be made available to theuser. For example, in diabetic healthcare maintenance, changes orfluctuations that occur in blood glucose levels during a day, a week, orlonger period can provide valuable information to a diabetic and/or hisor her healthcare professional. As previously mentioned, currentlyavailable systems do not allow associating blood glucose test resultswith attendant quantitative information relating to medication, foodintake, or other factors such as exercise that affect a person's bloodglucose level at any particular point in time. Thus, currently availableblood glucose monitoring systems have little or no capability for thegenerating and display of trend information that may be of significantvalue to a diabetic or the diabetic's healthcare professional.

Some currently available blood glucose monitoring systems provide a dataport that can be interconnected with and transfer data to a personalcomputer (e.g., via an RS-232 connection). With such a system and asuitable programmed computer, the user can generate and display trendinformation or other data that may be useful in administering his or hertreatment plan. Moreover, in such systems, data also can be transferredfrom the blood glucose monitoring system to a healthcare professional'scomputer either directly or remotely by telephone if both the bloodglucose monitoring system (or computer) to which the data has beendownloaded and the healthcare professional's computer are equipped withmodems. Although such a data transfer provision allows a healthcareprofessional to analyze blood glucose data collected by a diabetic, thisaspect of currently available blood glucose monitoring systems has notfound widespread application. First, the downloading and subsequentanalysis feature can only be used by system users that have ready accessto a computer that is programmed with appropriate software and, inaddition, have both the knowledge required to use the software (and theinclination to do so). This same problem exists with respect to datatransfer to (and subsequent analysis by) a healthcare professional.Moreover, various manufacturers of systems that currently provide a datatransfer feature do not use the same data format. Therefore, if ahealthcare professional wishes to analyze data supplied by a number ofdifferent blood glucose monitoring systems, he or she must possesssoftware for each of the systems and must learn to conduct the desiredanalyses with each software system.

The above-discussed disadvantages and drawbacks of microprocessor-basedself-care health monitoring systems take on even greater significancewith respect to children afflicted with diabetes, asthma and otherchronic illnesses. In particular, a child's need for medication andother therapy changes as the child grows. Current microprocessor-basedself-care health monitoring systems generally do not provide informationthat is timely and complete enough for a healthcare professional torecognize and avert problems before relatively severe symptoms develop.Too often, a need for a change in medication and/or other changes intherapeutic regimen is not detected until the child's condition worsensto the point that emergency room care is required.

Further, currently available microprocessor-based health monitoringsystems have not been designed with children in mind. As previouslymentioned, such devices are not configured for sufficient ease of use insituations in which it is desirable or necessary to record and trackquantitative information that affects the physical condition of thesystem user (e.g., medication dosage administered by a diabetic and foodintake). Children above the age at which they are generally capable ofobtaining blood samples and administering insulin or other medicationgenerally can learn to use at least the basic blood glucose monitoringfeatures of currently available microprocessor-based blood glucosemonitoring systems. However, the currently available monitoring systemsprovide nothing in the way of motivation for a child to use the deviceand, in addition, include little or nothing that educates the childabout his or her condition or treatment progress.

The lack of provision for the entering of alphanumeric data also can bea disadvantage. For example, currently available blood glucosemonitoring systems do not allow the user or the healthcare professionalto enter information into the system such as medication dosage and otherinstructions or data that is relevant to the user's self-care healthprogram.

The above-discussed disadvantages and drawbacks of currently availablemicroprocessor-based blood glucose monitoring systems also have beenimpediments to adopting the basic technology of the system for otherhealthcare situations in which establishing and maintaining an effectiveregimen for cure or control is dependent upon (or at least facilitatedby) periodically monitoring a condition and recording that conditionalong with time and date tags and other information necessary or helpfulin establishing and maintaining a healthcare program.

In the United States alone, over 100 million people have chronic healthconditions, accounting for an estimated $700 billion in annual medicalcosts. In an effort to control these medical costs, many healthcareproviders have initiated outpatient or home healthcare programs fortheir patients. The potential benefits of these programs areparticularly great for chronically ill patients who must treat theirdiseases on a daily basis. However, the success of these programs isdependent upon the ability of the healthcare providers to monitor thepatients remotely to avert medical problems before they becomecomplicated and costly. Unfortunately, no convenient and cost effectivemonitoring system exists for the patients who have the greatest need formonitoring, the poor and the elderly.

Prior attempts to monitor patients remotely have included the use ofpersonal computers and modems to establish communication betweenpatients and healthcare providers. However, computers are too expensiveto give away and the patients who already own computers are only a smallfraction of the total population. Further, the patients who owncomputers are typically young, well educated, and have good healthcarecoverage. Thus, these patients do not have the greatest unmet medicalneeds. The patients who have the greatest unmet medical needs are thepoor and elderly who do not own computers or who are unfamiliar withtheir use.

Similar attempts to establish communication between patients andhealthcare providers have included the use of the Internet and internetterminals. Although internet terminals are somewhat less costly thanpersonal computers, they are still too expensive to give away topatients. Moreover, monthly on-line access charges are prohibitive forpoor patients.

Other attempts to monitor patients remotely have included the use ofmedical monitoring devices with built-in modems. Examples of suchmonitoring devices include blood glucose meters, respiratory flowmeters, and heart rate monitors. Unfortunately, these monitoring devicesare only designed to collect physiological data from the patients. Theydo not allow flexible and dynamic querying of the patients for otherinformation, such as quality of life measures or psycho-social variablesof illness.

Prior attempts to monitor patients remotely have also included the useof interactive telephone or video response systems. Such interactivesystems are disclosed in U.S. Pat. No. 5,390,238 issued to Kirk et al.on Feb. 14, 1995, U.S. Pat. No. 5,434,611 issued to Tamura on Jul. 18,1995, and U.S. Pat. No. 5,441,047 issued to David et al. on Aug. 15,1995. One disadvantage of these systems is that they either require apatient to call in to a central facility to be monitored or require thecentral facility to call the patient according to a rigid monitoringschedule.

If the patients are required to call the central facility, only thecompliant patients will actually call regularly to be monitored.Non-compliant patients will typically wait until an emergency situationdevelops before contacting their healthcare provider, thus defeating thepurpose of the monitoring system. If the central facility calls eachpatient according to a monitoring schedule, it is intrusive to thepatient's life and resistance to the monitoring grows over time.

Another disadvantage of these conventional interactive response systemsis that they are prohibitively expensive for poor patients. Further, itis difficult to identify each patient uniquely using these systems.Moreover, these systems are generally incapable of collecting medicaldata from monitoring devices, such as blood glucose meters, respiratoryflow meters, or heart rate monitors.

OBJECTS AND ADVANTAGES OF THE INVENTION

In view of the above, it is an object of the present invention toprovide a simple and inexpensive system for remotely monitoring patientsand for communicating information to the patients. It is another objectof the invention to provide a system which allows flexible and dynamicquerying of the patients. It is a further object of the invention toprovide a system which combines querying of patients with medical devicemonitoring in the same monitoring session. Another object of theinvention is to provide a monitoring system which incurs lowercommunications charges than those incurred by conventional monitoringsystems. A further object of the invention is to provide a monitoringsystem which may be used at any time convenient for a patient.

These and other objects and advantages will become more apparent afterconsideration of the ensuing description and the accompanying drawings.

SUMMARY OF THE INVENTION

This invention provides a new and useful system for healthcaremaintenance in which the invention either serves as a peripheral deviceto (or incorporates) a small handheld microprocessor-based unit of thetype that includes a display screen, buttons or keys that allow a userto control the operation of the device and a program cartridge or otherarrangement that can be inserted in the device to adapt the device to aparticular application or function. The invention in effect converts thehandheld microprocessor device into a healthcare monitoring system thathas significant advantages over systems such as the currently availableblood glucose monitoring systems. To perform this conversion, theinvention includes a microprocessor-based healthcare data managementunit, a program cartridge and a monitoring unit. When inserted in thehandheld microprocessor unit, the program cartridge provides thesoftware necessary (program instructions) to program the handheldmicroprocessor unit for operation with the microprocessor-based datamanagement unit. Signal communication between the data management unitand the handheld microprocessor unit is established by an interfacecable. A second interface cable can be used to establish signalcommunication between the data management unit and the monitoring unitor, alternatively, the monitoring unit can be constructed as a plug-inunit having an electrical connector that mates with a connector mountedwithin a region that is configured for receiving the monitoring unit.

In operation, the control buttons or keys of the handheldmicroprocessor-based unit are used to select the operating mode for boththe data management unit and the handheld microprocessor-based unit. Inresponse to signals generated by the control buttons or keys, the datamanagement unit generates signals that are coupled to the handheldmicroprocessor unit and, under control of the program instructionscontained in the program cartridge, establish an appropriate screendisplay on the handheld microprocessor-based unit display. In selectingsystem operating mode and other operations, the control buttons are usedto position a cursor or other indicator in a manner that allows thesystem user to easily select a desired operating mode or function andprovide any other required operator input. In the disclosed detailedembodiment of the invention several modes of operation are madeavailable.

In the currently preferred embodiments of the invention, the handheldmicroprocessor unit is a compact video game system such as the systemmanufactured by Nintendo of America Inc. under the trademark “GAME BOY.”Use of a compact video game system has several general advantages,including the widespread availability and low cost of such systems.Further, such systems include switch arrangements that are easilyadapted for use in the invention and the display units of such systemsare of a size and resolution that can advantageously be employed in thepractice of the invention. In addition, such systems allow educationalor motivational material to be displayed to the system user, with thematerial being included in the program cartridge that provides themonitor system software or, alternatively, in a separate programcartridge.

The use of a compact video game system for the handheldmicroprocessor-based unit of the invention is especially advantageouswith respect to children. Specifically, the compact video game systemsof the type that can be employed in the practice of the invention arewell known and well accepted by children. Such devices are easilyoperated by a child and most children are well accustomed to using thedevices in the context of playing video games. Motivational andeducational material relating to the use of the invention can bepresented in game-like or animated format to further enhance acceptanceand use of the invention by children that require self-care healthmonitoring.

A microprocessor-based health monitoring system that is configured inaccordance with the invention provides additional advantages for boththe user and a healthcare professional. In accordance with one aspect ofthe invention, standardized reports are provided to a physician or otherhealthcare provider by means of facsimile transmission. To accomplishthis, the data management unit of the currently preferred embodiments ofthe invention include a modem which allows test results and other datastored in system memory to be transmitted to a remote clearinghouse viaa telephone connection. Data processing arrangements included in theclearinghouse perform any required additional data processing; formatthe standardized reports; and, transmit the reports to the facsimilemachine of the appropriate healthcare professional.

The clearinghouse also can fill an additional communication need,allowing information such as changes in medication dosage or otherinformation such as modification in the user's monitoring schedule to beelectronically sent to a system user. In arrangements that incorporatethis particular aspect of the invention, information can be sent to theuser via a telephone connection and the data management unit modem whena specific inquiry is initiated by the user, or when the userestablishes a telephone connection with the clearinghouse for otherpurposes such as providing data for standardized reports.

The clearinghouse-facsimile aspect of the invention is important becauseit allows a healthcare professional to receive timely information aboutpatient condition and progress without requiring a visit by the patient(system user) and without requiring analysis or processing of test databy the healthcare professional. In this regard, the healthcareprofessional need not possess or even know how to use a computer and/orthe software conventionally employed for analysis of blood glucose andother health monitoring data and information.

The invention also includes provision for data analysis and memorystorage of information provided by the user and/or the healthcareprofessional. In particular, the data management units of the currentlypreferred embodiments of the invention include a data port such as anRS-232 connection that allows the system user or healthcare professionalto establish signal communication between the data management unit and apersonal computer or other data processing arrangement. Blood glucosetest data or other information can then be downloaded for analysis andrecord keeping purposes. Alternatively, information such as changes inthe user's treatment and monitoring regimen can be entered into systemmemory. Moreover, if desired, remote communication between the datamanagement unit and the healthcare professional's computer can beestablished using the clearinghouse as an element of the communicationslink. That is, in the currently preferred arrangements of the inventiona healthcare professional has the option of using a personal computerthat communicates with the clearinghouse via a modem and telephone linefor purposes of transmitting instructions and information to a selecteduser of the system and/or obtaining user test data and information forsubsequent analysis.

The invention can be embodied in forms other than those described above.For example, although small handheld microprocessor-based units such asa handheld video game system or handheld microprocessor-based units ofthe type often referred to as “palm-top” computers provide manyadvantages, there are situations in which other compactmicroprocessor-based units can advantageously be used. Among the varioustypes of units that can be employed are using compact video game systemsof the type that employ a program cartridge, but uses a television setor video monitor instead of a display unit that is integrated into thepreviously described handheld microprocessor-based units.

Those skilled in the art also will recognize that the above-describedmicroprocessor-implemented functions and operations can be apportionedbetween one or more microprocessors in a manner that differs from theabove-described arrangement. For example, in some situations, theprogrammable microprocessor-based unit and the program cartridge used inpracticing the invention may provide memory and signal processingcapability that is sufficient for practicing the invention. In suchsituations, the microprocessor of the microprocessor-based datamanagement unit of the above-described embodiments in effect is movedinto the video game system, palm-top, computer or programmablemicroprocessor device. In such an arrangement, the data management unitcan be realized as a relatively simple interface unit that includeslittle or no signal processing capability. Depending upon the situationat hand, the interface unit may or may not include a telephone modemand/or an RS-232 connection (or other data port) for interconnecting thehealthcare system with a computer or other equipment. In othersituations, the functions and operations associated with processing ofthe monitored health care data may be performed by a microprocessor thatis added to or already present in the monitoring device that is used tomonitor blood glucose or other condition.

Because the invention can be embodied to establish systems havingdifferent levels of complexity, the invention satisfies a wide range ofself-care health monitoring applications. The arrangements that includea modem (or other signal transmission facility) and sufficient signalprocessing capability can be employed in situations in which reports areelectronically transmitted to a healthcare professional either in hardcopy (facsimile) form or in a signal format that can be received by andstored in the healthcare professional's computer. On the other hand,less complex (and, hence, less costly) embodiments of the invention areavailable for use in which transfer of system information need not bemade by means of telephonic data transfer or other remote transmissionmethods. In these less complex embodiments, transfer of data to ahealthcare professional can still be accomplished. Specifically, if theprogram cartridge includes a battery and suitable program instructions,monitored healthcare data can be stored in the program cartridge duringuse of the system as a healthcare monitor. The data cartridge can thenbe provided to the healthcare professional and inserted in aprogrammable microprocessor-based unit that is the same as or similar tothat which was used in the healthcare monitoring system. The healthcareprofessional can then review the data, and record it for later use,and/or can use the data in performing various analyses. If desired, themicroprocessor-based unit used by the healthcare professional can beprogrammed and arranged to allow information to be stored in thecartridge for return to and retrieval by the user of the healthcaremonitoring system. The stored information can include messages (e.g.,instructions for changes in medication dosage) and/or programinstructions for reconfiguring the program included in the cartridge soas to effect changes in the treatment regimen, the analyses or reportsto be generated by the healthcare monitoring system, or less importantaspects such as graphical presentation presented during the operation ofthe healthcare system.

The invention presents a networked system for remotely monitoring anindividual and for communicating information to the individual. Thesystem includes a server and a remote interface for entering in theserver a set of queries to be answered by the individual. The server ispreferably a world wide web server and the remote interface ispreferably a personal computer or network terminal connected to the webserver via the Internet. The system also includes a remotelyprogrammable apparatus for interacting with the individual. Theapparatus is connected to the server via a communication network,preferably the Internet. The apparatus interacts with the individual inaccordance with a script program received from the server.

The server includes a script generator for generating the script programfrom the queries entered through the remote interface. The scriptprogram is executable by the apparatus to communicate the queries to theindividual, to receive responses to the queries, and to transmit theresponses from the apparatus to the server. The server also includes adatabase connected to the script generator for storing the scriptprogram and the responses to the queries.

The apparatus has a communication device, such as a modem, for receivingthe script program from the server and for transmitting the responses tothe server. The apparatus also has a user interface for communicatingthe queries to the individual and for receiving the responses to thequeries. In the preferred embodiment, the user interface includes adisplay for displaying the queries and user input buttons for enteringthe responses to the queries. In an alternative embodiment, the userinterface includes a speech synthesizer for audibly communicating thequeries and a speech recognizer for receiving spoken responses to thequeries.

The apparatus also includes a memory for storing the script program andthe responses to the queries. The apparatus further includes amicroprocessor connected to the communication device, the userinterface, and the memory. The microprocessor executes the scriptprogram to communicate the queries to the individual, to receive theresponses to the queries, and to transmit the responses to the serverthrough the communication network.

In the preferred embodiment, the system also includes at least onemonitoring device for producing measurements of a physiologicalcondition of the individual and for transmitting the measurements to theapparatus. The apparatus further includes a device interface connectedto the microprocessor for receiving the measurements from the monitoringdevice. The measurements are stored in the memory and transmitted to theserver with the responses to the queries. The server also preferablyincludes a report generator connected to the database for generating areport of the measurements and responses. The report is displayed on theremote interface.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of thisinvention will become more readily appreciated as the same becomesbetter understood by reference to the following detailed description,when taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a block diagram that illustrates a healthcare monitoringsystem arranged in accordance with the invention;

FIG. 2 diagrammatically illustrates monitoring systems constructed inaccordance with the invention connected in signal communication with aremotely located computing facility which includes provision for makingthe data supplied by the monitoring system of the invention available toa designated healthcare professional and/or for providing data andinstructions to the system user;

FIG. 3 is a block diagram diagrammatically depicting the structuralarrangement of the system data management unit and its interconnectionwith other components of the system shown in FIG. 1;

FIGS. 4-10 depict typical system screen displays of data and informationthat can be provided by the arrangements shown in FIGS. 1-3; and

FIG. 11 diagrammatically illustrates an alternative healthcaremonitoring system that is arranged in accordance with the invention.

FIG. 12 is a block diagram of a networked system according to apreferred embodiment of the invention.

FIG. 13 is a block diagram illustrating the interaction of thecomponents of the system of FIG. 12.

FIG. 14 is a perspective view of a remotely programmable apparatus ofthe system of FIG. 12.

FIG. 15 is a block diagram illustrating the components of the apparatusof FIG. 14.

FIG. 16 is a script entry screen according to the preferred embodimentof the invention.

FIG. 17A is a listing of a sample script program according to thepreferred embodiment of the invention.

FIG. 17B is a continuation of the listing of FIG. 17A.

FIG. 18 is a script assignment screen according to the preferredembodiment of the invention.

FIG. 19 is a sample query appearing on a display of the apparatus ofFIG. 14.

FIG. 20 is a sample prompt appearing on the display of the apparatus ofFIG. 14.

FIG. 21 is a sample report displayed on a workstation of the system ofFIG. 12.

FIG. 22A is a flow chart illustrating the steps included in a monitoringapplication executed by the server of FIG. 12 according to the preferredembodiment of the invention.

FIG. 22B is a continuation of the flow chart of FIG. 22A.

FIG. 23A is a flow chart illustrating the steps included in the scriptprogram of FIGS. 17A-17B.

FIG. 23B is a continuation of the flow chart of FIG. 23A.

FIG. 24 is a perspective view of a remotely programmable apparatusaccording to a second embodiment of the invention.

FIG. 25 is a sample prompt appearing on a display of the apparatus ofFIG. 24.

FIG. 26 is a block diagram illustrating the components of the apparatusof FIG. 24.

FIG. 27 is a schematic block diagram illustrating the interaction of theserver of FIG. 12 with the apparatus of FIG. 14 according to a thirdembodiment of the invention.

FIG. 28 is a first sample message appearing on the display of theapparatus of FIG. 14.

FIG. 29 is a second sample message appearing on the display of theapparatus of FIG. 14.

FIG. 30 is a script entry screen according to the third embodiment ofthe invention.

FIG. 31 is a block diagram summarizing the Health Care ProviderApparatus of the present invention.

FIG. 32 is a block diagram summarizing the Remotely Programmable PatientApparatus of the present invention.

DETAILED DESCRIPTION

FIG. 1 depicts a self-care health monitoring system arranged inaccordance with the invention. In the arrangement shown in FIG. 1, adata management unit 10 is electrically interconnected with a handheldmicroprocessor-based unit 12 via a cable 14. In the depictedarrangement, data management unit 10 also is electrically interconnectedwith a blood glucose monitor 16 of the type capable of sensing bloodglucose level and producing an electrical signal representative thereof.Although FIG. 1 illustrates blood glucose monitor 16 as being connectedto data management unit 10 by a cable 18, it may be preferable toconstruct blood glucose monitor 16 as a plug-in unit that is placed in arecess or other suitable opening or slot in data management unit 10.Regardless of the manner in which blood glucose monitor 16 isinterconnected with data management unit 10, both that interconnectionand cable 14 are configured for serial data communication between theinterconnected devices.

Also shown in FIG. 1 are two additional monitoring devices 20 and 22,which are electrically connected for serial data communication with datamanagement unit 10 via cables 24 and 26, respectively. Monitoring units20 and 22 of FIG. 1 represent devices other than blood glucose monitor16 that can be used to configure the invention for self-care healthmonitoring applications other than (or in addition to) diabetes care.For example, as is indicated in FIG. 1, the monitoring device 20 can bea peak-flow meter that provides a digital signal representative of theairflow that results when a person suffering from asthma or anotherchronic respiratory affliction expels a breath of air through the meter.As is indicated by monitor 22 of FIG. 1, various other devices can beprovided for monitoring conditions such as blood pressure, pulse, andbody temperature to thereby realize systems for self-care monitoring andcontrol of conditions such as hypertension, certain heart conditions andvarious other afflictions and physical conditions. Upon understandingthe hereinafter discussed aspects and features of the invention it willbe recognized that the invention is easily implemented for these andother types of healthcare monitoring. In particular, monitors used inthe practice of the invention can be arranged in a variety of ways aslong as the data to be recorded or otherwise employed by handheldmicroprocessor unit 12 and/or data management unit 10 is provided inserial format in synchronization with clock signals provided by datamanagement unit 10. As is the case with blood glucose monitor 16, theadditional monitors can be configured as plug-in units that are directlyreceived by data management unit 10, or can be connected to datamanagement unit 10 with cables (as shown in FIG. 1).

As is shown in FIG. 1, handheld microprocessor unit 12 includes adisplay screen 28 and a plurality of switches or keys (30, 32, 34, 36,and 38 in FIG. 1), which are mounted on a housing 40. Located in theinterior of housing 40, but not shown in FIG. 1, are a microprocessor,memory circuits, and circuitry that interfaces switches 30, 32, 34, 36and 38 with the microprocessor. Stored in the memory of program handheldmicroprocessor unit 12 is a set of program instructions that establishesa data protocol that allows handheld microprocessor unit 12 to performdigital data signal processing and generate desired data or graphics fordisplay on display unit 28 when a program cartridge 42 is inserted in aslot or other receptacle in housing 40. That is, program cartridge 42 ofFIG. 1 includes read-only memory units (or other memory means such asbattery-powered random access memory) which store program instructionsand data that adapt handheld microprocessor 12 for operation in a bloodglucose monitoring system. More specifically, when the instructions anddata of program cartridge 42 are combined with program instructions anddata included in the internal memory circuits of handheld microprocessorunit 12, handheld microprocessor unit 12 is programmed for processingand displaying blood glucose information in the manner described belowand additional monitors 22 to provide health monitoring for asthma andvarious other previously mentioned chronic conditions. In each case, theplurality of switches or keys (30, 32, 34, 36, and 38 in FIG. 1) areselectively operated to provide signals that result in pictorial and/oralphanumeric information being displayed by display unit 42.

Various devices are known that meet the above-set forth description ofhandheld microprocessor unit 12. For example, compact devices areavailable in which the plurality of keys allows alphanumeric entry andinternal memory is provided for storing information such as names,addresses, phone numbers, and an appointment calendar. Small programcartridges or cards can be inserted in these devices to program thedevice for various purposes such as the playing of games, spreadsheetapplication, and foreign language translation sufficient for use intravel. More recently, less compact products that have more extensivecomputational capability and are generally called “palm top computers”have been introduced into the marketplace. These devices also caninclude provision for programming the device by means of an insertableprogram card or cartridge.

The currently preferred embodiments of the invention are configured andarranged to operate in conjunction with yet another type of handheldmicroprocessor unit. Specifically, in the currently preferredembodiments of the invention, program cartridge 42 is electrically andphysically compatible with commercially available compact video gamesystems, such as the system manufactured by Nintendo of America Inc.under the trademark “GAME BOY.” Configuring data management unit 10 andprogram cartridge 42 for operation with a handheld video game system hasseveral advantages. For example, the display unit of such a deviceprovides display resolution that allows the invention to display bothmulti-line alphanumeric information and graphical data. In this regard,the 160×144 pixel dot matrix-type liquid crystal display screencurrently used in the above-referenced compact video game systemsprovides sufficient resolution for at least six lines of alphanumerictext, as well as allowing graphical representation of statistical datasuch as graphical representation of blood glucose test results for aday, a week, or longer.

Another advantage of realizing handheld microprocessor unit 12 in theform of a compact video game system is the relatively simple, yetversatile arrangement of switches that is provided by such a device. Forexample, as is indicated in FIG. 1, a compact video game system includesa control pad 30 that allows an object displayed on display unit 42 tobe moved in a selected direction (i.e., up-down or left-right). As alsois indicated in FIG. 1, compact video game systems typically provide twopair of distinctly-shaped push button switches. In the arrangement shownin FIG. 1, a pair of spaced-apart circular push button switches (36 and38) and a pair of elongate switches (32 and 34) are provided. Thefunctions performed by the two pairs of switches is dependent upon theprogram instructions contained in each program cartridge 42.

Yet another advantage of utilizing a compact video game system forhandheld microprocessor-based unit 12 of FIG. 1 is the widespreadpopularity and low cost of such units. In this regard, manufacture andsale of a data management unit 10, blood glucose monitor 16 and programcartridge 42 that operate in conjunction with a compactmicroprocessor-based video allows the self-care health monitoring systemof FIG. 1 to be manufactured and sold at a lower cost than could berealized in an arrangement in which handheld unit 12 is designed andmanufactured solely for use in the system of FIG. 1.

An even further advantage of using a compact video game system forhandheld microprocessor 12 is that such video game systems include meansfor easily establishing the electrical interconnection provided by cable14 in FIG. 1. In particular, such compact video game systems include aconnector mounted to the game unit housing (40 in FIG. 1) and a cablethat can be connected between the connectors of two video game units toallow interactive operation of the two interconnected units (i.e., toallow contemporaneous game play by two players or competition betweenplayers as they individually play identical but separate games). In thepreferred embodiments of the invention, the “two-player” cable suppliedwith the compact video game unit being used as handheld microprocessorunit 12 is used as cable 14 to establish serial data communicationbetween the handheld microprocessor unit 12 (compact video game system)and data management unit 10. In these preferred embodiments, the programinstructions stored on the memory of data management unit 10 and programcartridge 42 respectively program data management unit 10 and thecompact video game system (i.e., handheld microprocessor unit 12) forinteractive operation in which switches 30, 32, 34, 36 and 38 are usedto control the operation of data management unit 10 (e.g., to select aparticular operational mode such as performance of a blood glucose testor the display of statistical test data and, in addition, to controloperation such as selection of an option during operation of the systemin a particular operational mode). In each operational mode, datamanagement unit 10 processes data in accordance with programinstructions stored in the memory circuits of data management unit 10.Depending upon the operational mode selected by the user, data issupplied to data management unit 10 by blood glucose monitor 16, byadditional monitors (20 and 22 in FIG. 1) or any interconnectedcomputers or data processing facility (such as the hereinafter describeduser's computer 48 and clearinghouse 54 of FIG. 1). During suchoperation, mode switches 30, 32, 34, 36 and 38 are selectively activatedso that signals are selectively coupled to the video game system(handheld microprocessor unit 12) and processed in accordance withprogram instructions stored in program cartridge 42. The signalprocessing performed by handheld microprocessor unit 12 results in thedisplay of alphanumeric, symbolic, or graphic information on the videogame display screen (i.e., display unit 28 in FIG. 1), which allow theuser to control system operation and obtain desired test results andother information.

Although the above-discussed advantages apply to use of the invention byall age groups, employing a compact video game system in the practice ofthe invention is of special significance in monitoring a child's bloodglucose or other health parameters. Children and young adults arefamiliar with compact video game systems. Thus, children will accept ahealth monitoring system incorporating a compact video game system morereadily than a traditional system, even an embodiment of the inventionthat uses a different type of handheld microprocessor unit. Moreover, anembodiment of the invention that functions in conjunction with a compactvideo game system can be arranged to motivate children to monitorthemselves more closely than they might otherwise by incorporatinggame-like features and/or animation in system instruction and testresult displays. Similarly, the program instructions can be included inprogram cartridges 41, 42 and 43 (or additional cartridges) that allowchildren to select game-like displays that help educate the child abouthis or her condition and the need for monitoring.

With continued reference to FIG. 1, data management unit 10 of thecurrently preferred embodiments of the invention includes a data port 44that allows communication between data management unit 10 and a personalcomputer 48 (or other programmable data processor). In the currentlypreferred embodiments of the invention, data port 44 is an RS-232connection that allows serial data communication between data managementunit 10 and personal computer 48. In the practice of the invention,personal computer 48 can be used to supplement data management unit 10by, for example, performing more complex analyses of blood glucose andother data that has been supplied to and stored in the memory circuitsof data management unit 10. With respect to embodiments of the inventionconfigured for use by a child, personal computer 48 can be used by aparent or guardian to review and analyze the child's progress and toproduce printed records for subsequent review by a healthcareprofessional. Alternatively, personal computer 48 can be used to supplydata to data management unit 10 that is not conveniently supplied byusing handheld microprocessor switches 30, 32, 34, 36 and 38 as anoperator interface to the system shown in FIG. 1. For example, someembodiments of the invention may employ a substantial amount ofalphanumeric information that must be entered by the system user.Although it is possible to enter such data by using switches 30, 32, 34,36 and 38 in conjunction with menus and selection screens displayed ondisplay screen 28 of FIG. 1, it may be more advantageous to use a devicesuch as personal computer 48 for entry of such data. However, ifpersonal computer 48 is used in this manner, some trade-off of systemfeatures may be required because data management unit 10 must betemporarily interconnected with personal computer 48 during theseoperations. That is, some loss of system mobility might result because asuitably programmed personal computer would be needed at each locationat which data entry or analysis is to occur.

As is indicated in FIG. 1, data management unit 10 of the currentlypreferred embodiments of the invention also includes a modem that allowsdata communication between data management unit 10 and a remotecomputing facility identified in FIG. 1 as clearinghouse 54 via aconventional telephone line (indicated by reference numeral 50 inFIG. 1) and a modem 52 that interconnects clearinghouse 54 and telephoneline 50. As shall be described in more detail, clearinghouse computingfacility 54 facilitates communication between a user of the system shownin FIG. 1 and his or her healthcare professional and can provideadditional services such as updating system software. As is indicated byfacsimile machine 55 of FIG. 1, a primary function of clearinghouse 54is providing the healthcare professional with standardized reports 56,which indicate both the current condition and condition trends of thesystem user. Although a single facsimile machine 55 is shown in FIG. 1,it will be recognized that numerous healthcare professionals (and hencefacsimile machine 55) can be connected in signal communication with aclearinghouse 54.

Regardless of whether a compact video game system, another type ofcommercially available handheld microprocessor-based unit, or aspecially designed unit is used, the preferred embodiments of FIG. 1provide a self-care blood glucose monitoring system in which programcartridge 42: (a) adapts handheld microprocessor unit 12 for displayinginstructions for performing the blood glucose test sequence andassociated calibration and test procedures; (b) adapts handheldmicroprocessor unit 12 for displaying (graphically or alphanumerically)statistical data such as blood glucose test results taken during aspecific period of time (e.g., a day, week, etc.); (c) adapts handheldmicroprocessor unit 12 for supplying control signals and signalsrepresentative of food intake or other useful information to datamanagement unit 10; (d) adapts handheld microprocessor unit 12 forsimultaneous graphical display of blood glucose levels with informationsuch as food intake; and, (e) adapts handheld microprocessor unit 12 fordisplaying information or instructions from a healthcare professionalthat are coupled to data management unit 10 from a clearinghouse 54. Themanner in which the arrangement of FIG. 1 implements the above-mentionedfunctions and others can be better understood with reference to FIGS. 2and 3.

Referring first to FIG. 2, clearinghouse 54 receives data from aplurality of self-care microprocessor-based healthcare systems of thetype shown in FIG. 1, with the individual self-care health monitoringsystems being indicated in FIG. 2 by reference numeral 58. Preferably,the data supplied to clearinghouse 54 by each individual self-carehealth monitoring system 58 consists of “raw data,” i.e., test resultsand related data that was stored in memory circuits of data managementunit 10, without further processing by data management unit 10. Forexample, with respect to the arrangement shown in FIG. 1, blood glucosetest results and associated data such as food intake information,medication dosage and other such conditions are transmitted toclearinghouse 54 and stored with a digitally encoded signal thatidentifies both the source of the information (i.e., the system user orpatient) and those having access to the stored information (i.e., thesystem user's doctor or other healthcare professional).

As shall be recognized upon understanding the manner in which itoperates, clearinghouse 54 can be considered to be a central server forthe various system users (58 in FIG. 2) and each healthcare professional60. In that regard, clearinghouse 54 includes conventionally arrangedand interconnected digital processing equipment (represented in FIG. 2by digital signal processor 57) which receives digitally encodedinformation from a user 58 or healthcare professional 60; processes theinformation as required; stores the information (processed orunprocessed) in memory if necessary; and, transmits the information toan intended recipient (i.e., user 58 or healthcare professional 60).

In FIG. 2, rectangular outline 60 represents one of numerous remotelylocated healthcare professionals who can utilize clearinghouse 54 andthe arrangement described relative to FIG. 1 in monitoring andcontrolling patient healthcare programs. Shown within outline 60 is acomputer 62 (e.g., personal computer), which is coupled to clearinghouse54 by means of a modem (not shown in FIG. 2) and a telephone line 64.Also shown in FIG. 2 is the previously mentioned facsimile machine 55,which is coupled to clearinghouse 54 by means of a second telephone line68. Using the interface unit of computer 62 (e.g., a keyboard orpointing device such as a mouse), the healthcare professional canestablish data communication between computer 62 and clearinghouse 54via telephone line 64. Once data communication is established betweencomputer 62 and clearinghouse 54, patient information can be obtainedfrom clearinghouse-54 in a manner similar to the manner in whichsubscribers to various database services access and obtain information.In particular, the healthcare professional can transmit an authorizationcode to clearinghouse 54 that identifies the healthcare professional asan authorized user of the clearinghouse and, in addition, can transmit asignal representing the patient for which healthcare information isbeing sought. As is the case with conventional database services andother arrangements, the identifying data is keyed into computer 62 bymeans of a conventional keyboard (not shown in FIG. 2) in response toprompts that are generated at clearinghouse 54 for display by thedisplay unit of computer 62 (not shown in FIG. 2).

Depending upon the hardware and software arrangement of clearinghouse 54and selections made by the healthcare professional via computer 62,patient information can be provided to the healthcare professional indifferent ways. For example, computer 62 can be operated to access datain the form that it is stored in the memory circuits of clearinghouse 54(i.e., raw data that has not been processed or altered by thecomputational or data processing arrangements of clearinghouse 54). Suchdata can be processed, analyzed, printed and/or displayed by computer 62using commercially available or custom software. On the other hand,various types of analyses may be performed by clearinghouse 54 with theresults of the analyses being transmitted to the remotely locatedhealthcare professional 60. For example, clearinghouse 54 can processand analyze data in a manner identical to the processing and analysisprovided by the self-care monitoring system of FIG. 1. With respect tosuch processing and any other analysis and processing provided byclearinghouse 54, results expressed in alphanumeric format can be sentto computer 62 via telephone line 64 and the modem associated withcomputer 62, with conventional techniques being used for displayingand/or printing the alphanumeric material for subsequent reference.

The arrangement of FIG. 2 also allows the healthcare professional tosend messages and/or instructions to each patient via computer 62,telephone line 64, and clearinghouse 54. In particular, clearinghouse 54can be programmed to generate a menu that is displayed by computer 62and allows the healthcare professional to select a mode of operation inwhich information is to be sent to clearinghouse 54 for subsequenttransmission to a user of the system described relative to FIG. 1. Thissame menu (or related submenus) can be used by the healthcareprofessional to select one or more modes of operation of theabove-described type in which either unmodified patient data or theresults of data that has been analyzed by clearinghouse 54 is providedto the healthcare provider via computer 62 and/or facsimile machine 55.

In the currently contemplated arrangements, operation of the arrangementof FIG. 2 to provide the user of the invention with messages orinstructions such as changes in medication or other aspects of thehealthcare program is similar to the operation that allows thehealthcare professional to access data sent by a patient, i.e.,transmitted to clearinghouse 54 by a data management unit 10 of FIG. 1.The process differs in that the healthcare professional enters thedesired message or instruction via the keyboard or other interface unitof computer 62. Once the data is entered and transmitted toclearinghouse 54, it is stored for subsequent transmission to the userfor whom the information or instruction is intended. With respect totransmitting stored messages or instructions to a user of the invention,at least two techniques are available. The first technique is based uponthe manner in which operational modes are selected in the practice ofthe invention. Specifically, in the currently preferred embodiments ofthe invention, program instructions that are stored in data managementunit 10 and program cartridge 42 cause the system of FIG. 1 to generatemenu screens which are displayed by display unit 28 of handheldmicroprocessor unit 12. The menu screens allow the system user to selectthe basic mode in which the system of FIG. 1 is to operate and, inaddition, allow the user to select operational subcategories within theselected mode of operation. Various techniques are known to thoseskilled in the art for displaying and selecting menu items. For example,in the practice of this invention, one or more main menus can begenerated and displayed which allow the system user to selectoperational modes that may include: (a) a monitor mode (e.g., monitoringof blood glucose level); (b) a display mode (e.g., displaying previouslyobtained blood glucose test results or other relevant information); (c)an input mode (e.g., a mode for entering data such as providinginformation that relates to the healthcare regimen, medication dosage,food intake, etc.); and, (d) a communications mode (for establishing acommunication link between data management unit 10 and personal computer48 of FIG. 1; or between data management unit 10 and a remote computingfacility such as clearinghouse 54 of FIG. 2).

In embodiments of the invention that employ a compact video game systemfor handheld microprocessor unit 12, the selection of menu screens andthe selection of menu screen items preferably is accomplished insubstantially the same manner as menu screens and menu items areselected during the playing of a video game. For example, the programinstructions stored in data management unit 10 and program cartridge 42of the arrangement of FIG. 1 can be established so that a predeterminedone of the compact video game switches (e.g., switch 32 in FIG. 1)allows the system user to select a desired main menu in the event thatmultiple main menus are employed. When the desired main menu isdisplayed, operation by the user of control pad 30 allows a cursor orother indicator that is displayed on the menu to be positioned adjacentto or over the menu item to be selected. Activation of a switch (e.g.,switch 36 of the depicted handheld microprocessor unit 12) causes thehandheld microprocessor unit 12 and/or data management unit 10 toinitiate the selected operational mode or, if selection of operationalsubmodes is required, causes handheld microprocessor unit 12 to displaya submenu.

In view of the above-described manner in which menus and submenus areselected and displayed, it can be recognized that the arrangement ofFIG. 1 can be configured and arranged to display a menu or submenu itemthat allows the user to obtain and display messages or instructions thathave been provided by a healthcare professional and stored inclearinghouse 54. For example, a submenu that is generated uponselection of the previously mentioned communications mode can includesubmenu items that allow the user to select various communication modes,including a mode in which serial data communication is establishedbetween data management unit 10 and clearinghouse 54 and data managementunit 10 transmits a message status request to clearinghouse 54. Whenthis technique is used, the data processing system of clearinghouse 54is programmed to search the clearinghouse memory to determine whether amessage exists for the user making the request. Any messages stored inmemory for that user are then transmitted to the user and processed fordisplay on display unit 28 of handheld microprocessor unit 12. If nomessages exist, clearinghouse 54 transmits a signal that causes displayunit 28 to indicate “no messages.” In this arrangement, clearinghouse 54preferably is programmed to store a signal indicating that a storedmessage has been transmitted to the intended recipient (user). Storingsuch a signal allows the healthcare professional to determine thatmessages sent to clearinghouse 54 for forwarding to a patient have beentransmitted to that patient. In addition, the program instructionsstored in data management unit 10 of FIG. 1 preferably allow the systemuser to designate whether received messages and instructions are to bestored in the memory of data management unit 10 for subsequent retrievalor review. In addition, in some instances it may be desirable to programclearinghouse 54 and data management unit 10 so that the healthcareprofessional can designate (i.e., flag) information such as changes inmedication that will be prominently displayed to the user (e.g.,accompanied by a blinking indicator) and stored in the memory of datamanagement unit 10 regardless of whether the system user designates theinformation for storage.

A second technique that can be used for forwarding messages orinstructions to a user does not require the system user to select a menuitem requesting transmission by clearinghouse 54 of messages that havebeen stored for forwarding to that user. In particular, clearinghouse 54can be programmed to operate in a manner that either automaticallytransmits stored messages for that user when the user operates thesystem of FIG. 1 to send information to the clearinghouse or programmedto operate in a manner that informs the user that messages are availableand allows the user to access the messages when lie or she chooses to doso.

Practicing the invention in an environment in which the healthcareprofessional uses a personal computer in some or all of theabove-discussed ways can be very advantageous. On the other hand, theinvention also provides healthcare professionals timely informationabout system users without the need for a computer (62 in FIG. 2) or anyequipment other than a conventional facsimile machine (55 in FIGS. 1 and2). Specifically, information provided to clearinghouse 54 by a systemuser 58 can be sent to a healthcare professional 60 via telephone line68 and facsimile machine 55, with the information being formatted as astandardized graphic or textual report (56 in FIG. 1). Formatting astandardized report 56 (i.e., analyzing and processing data supplied byblood glucose monitor 16 or other system monitor or sensor) can beeffected either by data management unit 10 or within the clearinghousefacility 54. Moreover, various standardized reports can be provided(e.g., the textual and graphic displays discussed below relating toFIGS. 6-10). Preferably, the signal processing arrangement included inclearinghouse 54 allows each healthcare professional 60 to select whichof several standardized reports will be routinely transmitted to thehealthcare professionals' facsimile machine 55, and, to do so on apatient-by-patient (user-by-user) basis.

FIG. 3 illustrates the manner in which data management unit 10 isarranged and interconnected with other system components for effectingthe above-described operational aspects of the invention and additionalaspects that are described relative to FIGS. 4-10. As is symbolicallyindicated in FIG. 3, handheld microprocessor unit 12 and blood glucosemonitor 16 are connected to a dual universal asynchronous receivertransmitter 70 (e.g., by cables 14 and 18 of FIG. 1, respectively). Asalso is indicated in FIG. 3 when a system user connects a personalcomputer 48 (or other programmable digital signal processor) to dataport 44, signal communication is established between personal computer48 and a second dual universal asynchronous receiver transmitter 72 ofdata management unit 10. Additionally, dual universal asynchronousreceiver transmitter 72 is coupled to modem 46 so that datacommunication can be established between data management unit 10 and aremote clearinghouse 54 of FIGS. 1 and 2.

Currently preferred embodiments of data management unit 10 include aplurality of signal sensors 74, with an individual signal sensor beingassociated with each device that is (or may be) interconnected with datamanagement unit 10. As previously discussed and as is indicated in FIG.3, these devices include handheld microprocessor unit 12, blood glucosemonitor 16, personal computer 48, remote computing facility 54 and, inaddition, peak-flow meter 20 or other additional monitoring devices 22.Each signal sensor 74 that is included in data management unit 10 iselectrically connected for receiving a signal that will be present whenthe device with which that particular signal sensor is associated isconnected to data management unit 10 and, in addition, is energized(e.g., turned on). For example, in previously mentioned embodiments ofthe invention in which data port 44 is an RS-232 connection, the signalsensor 74 that is associated with personal computer 48 can be connectedto an RS-232 terminal that is supplied power when a personal computer isconnected to data port 44 and the personal computer is turned on. In asimilar manner, the signal sensor 74 that is associated withclearinghouse 54 can be connected to modem 46 so that the signal sensor74 receives an electrical signal when modem 46 is interconnected to aremote computing facility (e.g., clearinghouse 54 of FIG. 2) via atelephone line 50.

In the arrangement of FIG. 3, each signal sensor 74 is a low powerswitch circuit (e.g., a metal-oxide semiconductor field-effecttransistor circuit), which automatically energizes data management unit10 whenever any one (or more) of the devices associated with signalsensors 74 is connected to data management unit 10 and is energized.Thus, as is indicated in FIG. 3 by signal path 76, each signal sensor 74is interconnected with power supply 78, which supplies operating currentto the circuitry of data management unit 10 and typically consists ofone or more small batteries (e.g., three AAA alkaline cells).

The microprocessor and other conventional circuitry that enables datamanagement unit 10 to process system signals in accordance with storedprogram instructions is indicated in FIG. 3 by central processing unit(CPU) 80. As is indicated in FIG. 3 by interconnection 82 between CPU 80and battery 78, CPU 80 receives operating current from power supply 78,with power being provided only when one or more of the signal sensors 74are activated in the previously described manner. A clock/calendarcircuit 84 is connected to CPU 80 (via signal path 86 in FIG. 3) toallow time and date tagging of blood glucose tests and otherinformation. Although not specifically shown in FIG. 3, operating poweris supplied to clock/calendar 84 at all times.

In operation, CPU 80 receives and sends signals via a data bus(indicated by signal path 88 in FIG. 3) which interconnects CPU 80 withdual universal asynchronous receiver transmitters 70 and 72. The databus 88 also interconnects CPU 80 with memory circuits which, in thedepicted embodiment, include a system read-only memory (ROM) 90, aprogram random access memory (RAM) 92, and an electronically erasableread-only memory (EEROM) 94. System ROM 90 stores program instructionsand any data required in order to program data management unit 10 sothat data management unit 10 and a handheld microprocessor unit 12 thatis programmed with a suitable program cartridge 72 provide thepreviously discussed system operation and, in addition, system operationof the type described relative to FIGS. 4-10. During operation of thesystem, program RAM 92 provides memory space that allows CPU 80 to carryout various operations that are required for sequencing and controllingthe operation of the system of FIG. 1. In addition, RAM 92 can providememory space that allows external programs (e.g., programs provided byclearinghouse 54) to be stored and executed. EEROM 94 allows bloodglucose test results and other data information to be stored andpreserved until the information is no longer needed (i.e., untilpurposely erased by operating the system to provide an appropriate erasesignal to EEROM 94).

FIGS. 4-10 illustrate typical screen displays that are generated by thearrangement of the invention described relative to FIGS. 1-3. Referencewill first be made to FIGS. 4 and 5, which exemplify screen displaysthat are associated with operation of the invention in the blood glucosemonitoring mode. Specifically, in the currently preferred embodiments ofthe invention, blood glucose monitor 16 operates in conjunction withdata management unit 10 and handheld microprocessor unit 12 to: (a)perform a test or calibration sequence in which tests are performed toconfirm that the system is operating properly; and, (b) perform theblood glucose test sequence in which blood glucose meter 16 senses theusers blood glucose level. Suitable calibration procedures for bloodglucose monitors are known in the art. For example, blood glucosemonitors often are supplied with a “code strip,” that is inserted in themonitor and results in a predetermined value being displayed and storedin memory at the conclusion of the code strip calibration procedure.When such a code strip calibration procedure is used in the practice ofthe invention, the procedure is selected from one of the system menus.For example, if the system main menu includes a “monitor” menu item, asubmenu displaying system calibration options and an option forinitiating the blood glucose test may be displayed when the monitor menuitem is selected. When a code strip option is available and selected, asequence of instructions is generated and displayed by display screen 28of handheld microprocessor unit 12 to prompt the user to insert the codestrip and perform all other required operations. At the conclusion ofthe code strip calibration sequence, display unit 28 of handheldmicroprocessor unit 12 displays a message indicating whether or not thecalibration procedure has been successfully completed. For example, FIG.4 illustrates a screen display that informs the system user that thecalibration procedure was not successful and that the code strip shouldbe inserted again (i.e., the calibration procedure is to be repeated).As is indicated in FIG. 4, display screens that indicate a potentialmalfunction of the system include a prominent message such as the“Attention” notation included in the screen display of FIG. 4.

As previously indicated, the blood glucose test sequence that isemployed in the currently preferred embodiment of the invention is ofthe type in which a test strip is inserted in a receptacle that isformed in the blood glucose monitor. A drop of the user's blood is thenapplied to the test strip and a blood glucose sensing sequence isinitiated. When the blood glucose sensing sequence is complete, theuser's blood glucose level is displayed.

In the practice of the invention, program instructions stored in datamanagement unit 10 (e.g., system ROM 90 of FIG. 3) and programinstructions stored in program cartridge 42 of handheld microprocessorunit 12 cause the system to display step-by-step monitoring instructionsto the system user and, in addition, preferably result in display ofdiagnostic messages if the test sequence does not proceed in a normalfashion. Although currently available self-containedmicroprocessor-based blood glucose monitors also display testinstruction and diagnostic messages, the invention provides greatermessage capacity and allows multi-line instructions and diagnosticmessages that are displayed in easily understood language rather thancryptic error codes and abbreviated phraseology that is displayed oneline or less at a time. For example, as is shown in FIG. 5, the completeresults of a blood glucose test (date, time of day, and blood glucoselevel in milligrams per deciliter) can be concurrently displayed bydisplay screen 28 of handheld microprocessor unit 12 along with aninstruction to remove the test strip from blood glucose monitor 16. Aspreviously mentioned, when the blood glucose test is complete, the timeand date tagged blood glucose test result is stored in the memorycircuits of data management unit 10 (e.g., stored in EEPROM 94 of FIG.3).

The arrangement shown and described relative to FIGS. 1-3 also isadvantageous in that data relating to food intake, concurrent medicationdosage and other conditions easily can be entered into the system andstored with the time and date tagged blood glucose test result for laterreview and analysis by the user and/or his or her healthcareprofessional. Specifically, a menu generated by the system at thebeginning or end of the blood glucose monitoring sequence can includeitems such as “hypoglycemic” and “hyperglycemic,” which can be selectedusing the switches of handheld microprocessor unit 12 (e.g., operationof control pad 30 and switch 36 in FIG. 1) to indicate the user wasexperiencing hypoglycemic or hyperglycemic symptoms at the time ofmonitoring blood glucose level. Food intake can be quantitativelyentered in terms of “Bread Exchange” units or other suitable terms by,for example, selecting a food intake menu item and using a submenudisplay and the switches of handheld microprocessor 12 to select andenter the appropriate information. A similar menu item—submenu selectionprocess also can be used to enter medication data such as the type ofinsulin used at the time of the glucose monitoring sequence and thedosage.

As was previously mentioned, program instructions stored in datamanagement unit 10 and program instructions stored in program cartridge42 of handheld microprocessor unit 12 enable the system to displaystatistical and trend information either in a graphic or alphanumericformat. As is the case relative to controlling other operational aspectsof the system, menu screens are provided that allow the system user toselect the information that is to be displayed. For example, in thepreviously discussed embodiments in which a system menu includes a“display” menu item, selection of the menu item results in the displayof one or more submenus that list available display options. Forexample, in the currently preferred embodiments, the user can selectgraphic display of blood glucose test results over a specific period oftime, such as one day, or a particular week. Such selection results indisplays of the type shown in FIGS. 6 and 7, respectively. When bloodglucose test results for a single day are displayed (FIG. 6), the day ofthe week and date can be displayed along with a graphic representationof changes in blood glucose level between the times at which testresults were obtained. In the display of FIG. 6, small icons identifypoints on the graphic representation that correspond to the bloodglucose test results (actual samples). Although not shown in FIG. 6,coordinate values for blood glucose level and time of day can bedisplayed if desired. When the user chooses to display a weekly trendgraph (FIG. 7), the display generated by the system is similar to thedisplay of a daily graph, having the time period displayed inconjunction with a graph that consists of lines interconnecting pointsthat correspond to the blood glucose test results.

The screen display shown in FIG. 8 is representative of statistical datathat can be determined by the system of FIG. 1 (using conventionalcomputation techniques) and displayed in alphanumeric format. Aspreviously mentioned, such statistical data and information in variousother textual and graphic formats can be provided to a healthcareprofessional (60 in FIG. 2) in the form of a standardized report 56(FIG. 1) that is sent by clearinghouse 54 to facsimile machine 55. Inthe exemplary screen display of FIG. 8, statistical data for bloodglucose levels over a period of time (e.g., one week) or, alternatively,for a specified number of monitoring tests is provided. In the exemplarydisplay of FIG. 8, the system (data management unit 10 or clearinghouse54) also calculates and displays (or prints) the average blood glucoselevel and the standard deviation. Displayed also is the number of bloodglucose test results that were analyzed to obtain the average and thestandard deviation; the number of test results under a predeterminedlevel (50 milligrams per deciliter in FIG. 8); and the number of bloodglucose tests that were conducted while the user was experiencinghypoglycemic symptoms. As previously noted, in the preferred embodimentsof the invention, a screen display that is generated during the bloodglucose monitoring sequence allows the user to identify the blood samplebeing tested as one taken while experiencing hyperglycemic orhypoglycemic symptoms and, in addition, allows the user to specify otherrelevant information such as food intake and medication information.

The currently preferred embodiments of the invention also allow the userto select a display menu item that enables the user to sequentiallyaddress, in, chronological order, the record of each blood glucose test.As is indicated in FIG. 9, each record presented to the system userincludes the date and time at which the test was conducted, the bloodglucose level, and any other information that the user provided. Forexample, the screen display of FIG. 9 indicates that the user employedhandheld microprocessor unit 12 as an interface to enter data indicatinguse of 12.5 units of regular insulin; 13.2 units of “NPH” insulin; foodintake of one bread exchange unit; and pre-meal hypoglycemic symptoms.

Use of data management unit 10 in conjunction with handheldmicroprocessor unit 12 also allows display (or subsequent generation ofa standardized report 56) showing blood glucose test results along withfood intake and/or medication information. For example, shown in FIG. 10is a daily graph in which blood glucose level is displayed in the mannerdescribed relative to FIG. 6. Related food intake and medication dosageis indicated directly below contemporaneous blood glucose levels byvertical bar graphs.

It will be recognized by those skilled in the art that theabove-described screen displays and system operation can readily beattained with conventional programming techniques of the type typicallyused in programming microprocessor arrangements. It also will berecognized by those skilled in the art that various other types ofscreen displays can be generated and, in addition, that numerous otherchanges can be made in the embodiments described herein withoutdeparting from the scope and the spirit of the invention.

It will also be recognized by those skilled in the art that theinvention can be embodied in forms other than the embodiments describedrelative to FIGS. 1-10. For example, the invention can employ compactvideo game systems that are configured differently than the previouslydiscussed handheld video game systems and palm-top computers. Morespecifically, as is shown in FIG. 11, a self-care health monitoringsystem arranged in accordance with the invention can employ a compactvideo game system of the type that includes one or more controllers 100that are interconnected to a game console 102 via cable 104. As isindicated in FIG. 11, game console 102 is connected to a video monitoror television 106 by means of a cable 108. Although differing inphysical configuration, controller 100, game console 102 and thetelevision or video monitor 106 collectively function in the same manneras the handheld microprocessor 12 of FIG. 1. In that regard, a programcartridge 42 is inserted into a receptacle contained in game console102, with program cartridge 42 including stored program instructions forcontrolling microprocessor circuitry that is located inside game console102. Controller 100 includes a control pad or other device functionallyequivalent to control pad 30 of FIG. 1 and switches that functionallycorrespond to switches 32-38 of FIG. 1.

Regardless of whether the invention is embodied with a handheldmicroprocessor unit (FIG. 1) or an arrangement such as the compact videogame system (FIG. 11), in some cases it is both possible andadvantageous to apportion the signal processing functions and operationsdifferently than was described relative to FIGS. 1-10. For example, insome situations, the microprocessor-based unit that is programmed by acard or cartridge (e.g., handheld unit 12 of FIG. 1 or compact videogame console 102 of FIG. 11) includes memory and signal processingcapability that allows the microprocessor to perform all or most of thefunctions and operations attributed to data management unit 10 of theembodiments discussed relative to FIGS. 1-10. That is, the digitallyencoded signal supplied by blood glucose monitor 16 (or one of the othermonitors 20 and 22 of FIG. 1) can be directly coupled to themicroprocessor included in game console 102 of FIG. 11 or handheldmicroprocessor 12 of FIG. 1. In such an arrangement, the data managementunit is a relatively simple signal interface (e.g., interface unit 110of FIG. 11), the primary purpose of which is carrying signals betweenthe blood glucose monitor 16 (or other monitor) and the microprocessorof game console 102 (FIG. 11) or handheld unit 12 (FIG. 1). In somesituations, the interface unit may consist primarily or entirely of aconventional cable arrangement such as a cable for interconnectionbetween RS232 data ports or other conventional connection arrangements.On the other hand, as is shown in FIG. 11, signal interface 110 caneither internally include or be connected to a modem 52, which receivesand transmits signals via a telephone line 50 in the manner describedrelative to FIGS. 1 and 2.

It also should be noted that all or a portion of the functions andoperations attributed to data management unit 10 of FIG. 1 can beperformed by microprocessor circuitry located in blood glucose monitor16 (or other monitor that is used with the system). For example, anumber of commercially available blood glucose monitors include aclock/calendar circuit of the type described relative to FIG. 3 and, inaddition, include microprocessor circuitry for generating visual displaysignals and signals representative of both current and past values ofmonitored blood glucose level. Conventional programming and designtechniques can be employed to adapt such commercially available unitsfor the performance of the various functions and operations attributedin the above discussion of FIGS. 1-11 to data management unit 10 and/orthe microprocessors of handheld unit 12 and compact video console 102.In arrangements in which the blood glucose monitor (or other systemmonitor) includes a microprocessor that is programmed to provide signalprocessing in the above-described manner, the invention can use a signalinterface unit 110 of the above-described type. That is, depending uponthe amount of signal processing effected by the monitoring unit (e.g.,blood glucose monitor 16) and the amount of signal processing performedby the microprocessor of video game console 102 (or handheld unit 12),the signal interface required ranges from a conventional cable (e.g.,interconnection of RS232 ports) to an arrangement in which signalinterface 110 is arranged for signal communication with an internal orexternal modem (e.g., modem 52 of FIG. 11) or an arrangement in whichsignal interface 110 provides only a portion of the signal processingdescribed relative to FIGS. 1-10.

The invention also is capable of transmitting information to a remotelocation (e.g., clearinghouse 54 and/or a remotely located healthcareprofessional) by means other than conventional telephone lines. Forexample, a modem (52 in FIGS. 1 and 11) that is configured for use witha cellular telephone system can be employed to transmit the signalsprovided by the healthcare monitoring system to a remote location viamodulated RF transmission. Moreover, the invention can be employed withvarious digital networks such as recently developed interactive voice,video and data systems such as television systems in which a televisionand user interface apparatus is interactively coupled to a remotelocation via coaxial or fiberoptic cable and other transmission media(indicated in FIG. 11 by cable 112, which is connected to television orvideo monitor 106). In such an arrangement, compact video gamecontroller 100 and the microprocessor of video game console 102 can beprogrammed to provide the user interface functions required fortransmission and reception of signals via the interactive system.Alternatively, the signals provided by video game console 102 (orhandheld unit 12 if FIG. 1) can be supplied to the user interface of theinteractive system (not shown in FIG. 11) in a format that is compatiblewith the interactive system and allows the system user interface to beused to control signal transmission between the healthcare system and aremote facility such as clearinghouse 54, FIGS. 1 and 2.

The invention presents a system and method for remotely monitoringindividuals and for communicating information to the individuals. In apreferred embodiment of the invention, the individuals are patients andthe system is used to collect data relating to the health status of thepatients. However, it is to be understood that the invention is notlimited to remote patient monitoring. The system and method of theinvention may be used for any type of remote monitoring application. Theinvention may also be implemented as an automated messaging system forcommunicating information to individuals, as will be discussed in analternative embodiment below.

A preferred embodiment of the invention is illustrated in FIGS. 12-23.Referring to FIG. 12, a networked system 2016 includes a server 2018 anda workstation 2020 connected to server 2018 through a communicationnetwork 2024. Server 2018 is preferably a world wide web server andcommunication network 2024 is preferably the Internet. It will beapparent to one skilled in the art that server 2018 may comprise asingle stand-alone computer or multiple computers distributed throughouta network. Workstation 2020 is preferably a personal computer, remoteterminal, or web TV unit connected to server 2018 via the Internet.Workstation 2020 functions as a remote interface for entering in server2018 messages and queries to be communicated to the patients.

System 2016 also includes first and second remotely programmableapparatuses 2026 and 2032 for monitoring first and second patients,respectively. Each apparatus is designed to interact with a patient inaccordance with script programs received from server 2018. Eachapparatus is in communication with server 2018 through communicationnetwork 2024, preferably the Internet. Alternatively, each apparatus maybe placed in communication with server 2018 via wireless communicationnetworks, cellular networks, telephone networks, or any other networkwhich allows each apparatus to exchange data with server 2018. Forclarity of illustration, only two apparatuses are shown in FIG. 12. Itis to be understood that system 2016 may include any number ofapparatuses for monitoring any number of patients.

In the preferred embodiment, each patient to be monitored is alsoprovided with a monitoring device 2028. Monitoring device 2028 isdesigned to produce measurements of a physiological condition of thepatient, record the measurements, and transmit the measurements to thepatient's apparatus through a standard connection cable 2030. Examplesof suitable monitoring devices include blood glucose meters, respiratoryflow meters, blood pressure cuffs, electronic weight scales, and pulserate monitors. Such monitoring devices are well known in the art. Thespecific type of monitoring device provided to each patient is dependentupon the patient's disease. For example, diabetes patients are providedwith a blood glucose meters for measuring blood glucose concentrations,asthma patients are provided with respiratory flow meters for measuringpeak flow rates, obesity patients are provided with weight scales, etc.

FIG. 13 shows server 2018, workstation 2020, and apparatus 2026 ingreater detail. Server 2018 includes a database 2038 for storing scriptprograms 2040. The script programs are executed by each apparatus tocommunicate queries and messages to a patient, receive responses 2042 tothe queries, collect monitoring device measurements 2044, and transmitresponses 2042 and measurements 2044 to server 2018. Database 2038 isdesigned to store the responses 2042 and measurements 2044. Database2038 further includes a look-up table 2046. Table 2046 contains a listof the patients to be monitored, and for each patient, a unique patientidentification code and a respective pointer to the script programassigned to the patient. Each remote apparatus is designed to executeassigned script programs which it receives from server 2018.

FIGS. 14-15 show the structure of each apparatus according to thepreferred embodiment. For clarity, only apparatus 2026 is shown sinceeach apparatus of the preferred embodiment has substantially identicalstructure to apparatus 2026. Referring to FIG. 14, apparatus 2026includes a housing 2062. Housing 2062 is sufficiently compact to enableapparatus 2026 to be hand-held and carried by a patient. Apparatus 2026also includes a display 2064 for displaying queries and prompts to thepatient. In the preferred embodiment, display 2064 is a liquid crystaldisplay (LCD).

Four user input buttons 2070A, 2070B, 2070C, and 2070D are locatedadjacent display 2064. The user input buttons are for entering inapparatus 2026 responses to the queries and prompts. In the preferredembodiment, the user input buttons are momentary contact push buttons.In alternative embodiments, the user input buttons may be replaced byswitches, keys, a touch sensitive display screen, or any other datainput device.

Three monitoring device jacks 2068A, 2068B, and 2068C are located on asurface of housing 2062. The device jacks are for connecting apparatus2026 to a number of monitoring devices, such as blood glucose meters,respiratory flow meters, or blood pressure cuffs, through respectiveconnection cables (not shown). Apparatus 2026 also includes a modem jack2066 for connecting apparatus 2026 to a telephone jack through astandard connection cord (not shown). Apparatus 2026 further includes avisual indicator, such as a light emitting diode (LED) 2074. LED 2074 isfor visually notifying the patient that he or she has unanswered queriesstored in apparatus 2026.

FIG. 15 is a schematic block diagram illustrating the components ofapparatus 2026 in greater detail. Apparatus 2026 includes amicroprocessor 2076 and a memory 2080 connected to microprocessor 2076.Memory 2080 is preferably a non-volatile memory, such as a serialEEPROM. Memory 2080 stores script programs received from the server,measurements received from monitoring device 2028, responses to queries,and the patient's unique identification code. Microprocessor 2076 alsoincludes built-in read only memory (ROM) which stores firmware forcontrolling the operation of apparatus 2026. The firmware includes ascript interpreter used by microprocessor 2076 to execute the scriptprograms. The script interpreter interprets script commands which areexecuted by microprocessor 2076. Specific techniques for interpretingand executing script commands in this manner are well known in the art.

Microprocessor 2076 is preferably connected to memory 2080 using astandard two-wire I²C interface. Microprocessor 2076 is also connectedto user input buttons 2070, LED 2074, a clock 2084, and a display driver2082. Clock 2084 indicates the current date and time to microprocessor2076. For clarity of illustration, clock 2084 is shown as a separatecomponent, but is preferably built into microprocessor 2076. Displaydriver 2082 operates under the control of microprocessor 2076 to displayinformation on display 2064. Microprocessor 2076 is preferably a PIC16C65 processor which includes a universal asynchronous receivertransmitter (UART) 2078. UART 2078 is for communicating with a modem2086 and a device interface 2090. A CMOS switch 2088 under the controlof microprocessor 2076 alternately connects modem 2086 and interface2090 to UART 2078.

Modem 2086 is connected to a telephone jack 2022 through modem jack2066. Modem 2086 is for exchanging data with server 2018 throughcommunication network 2024. The data includes script programs which arereceived from the server as well as responses to queries, devicemeasurements, script identification codes, and the patient's uniqueidentification code which modem 2086 transmits to the server. Modem 2086is preferably a complete 28.8 K modem commercially available fromCermetek, although any suitable modem may be used.

Device interface 2090 is connected to device jacks 2068A, 2068B, and2068C. Device interface 2090 is for interfacing with a number ofmonitoring devices, such as blood glucose meters, respiratory flowmeters, blood pressure cuffs, weight scales, or pulse rate monitors,through the device jacks. Device interface 2090 operates under thecontrol of microprocessor 2076 to collect measurements from themonitoring devices and to output the measurements to microprocessor 2076for storage in memory 2080. In the preferred embodiment, interface 2090is a standard RS232 interface. For simplicity of illustration, only onedevice interface is shown in FIG. 15. However, in alternativeembodiments, apparatus 2026 may include multiple device interfaces toaccommodate monitoring devices which have different connectionstandards.

Referring again to FIG. 13, server 2018 includes a monitoringapplication 2048. Monitoring application 2048 is a controlling softwareapplication executed by server 2018 to perform the various functionsdescribed below. Application 2048 includes a script generator 2050, ascript assignor 2052, and a report generator 2054. Script generator 2050is designed to generate script programs 2040 from script informationentered through workstation 2020. The script information is enteredthrough a script entry screen 2056. In the preferred embodiment, scriptentry screen 2056 is implemented as a web page on server 2018.Workstation 2020 includes a web browser for accessing the web page toenter the script information.

FIG. 16 illustrates script entry screen 2056 as it appears onworkstation 2020. Screen 2056 includes a script name field 2092 forspecifying the name of a script program to be generated. Screen 2056also includes entry fields 2094 for entering a set of queries to beanswered by a patient. Each entry field 2094 has corresponding responsechoice fields 2096 for entering response choices for the query. Screen2056 further includes check boxes 2098 for selecting a desiredmonitoring device from which to collect measurements, such as a bloodglucose meter, respiratory flow meter, or blood pressure cuff.

Screen 2056 additionally includes a connection time field 2100 forspecifying a prescribed connection time at which each apparatusexecuting the script is to establish a subsequent communication link tothe server. The connection time is preferably selected to be the time atwhich communication rates are the lowest, such as 3:00 AM. Screen 2056also includes a CREATE SCRIPT button 2102 for instructing the scriptgenerator to generate a script program from the information entered inscreen 2056. Screen 2056 further includes a CANCEL button 2104 forcanceling the information entered in screen 2056.

In the preferred embodiment, each script program created by the scriptgenerator conforms to the standard file format used on UNIX systems. Inthe standard file format, each command is listed in the upper case andfollowed by a colon. Every line in the script program is terminated by alinefeed character {LF}, and only one command is placed on each line.The last character in the script program is a UNIX end of file character{EOF}. Table 1 shows an exemplary listing of script commands used in thepreferred embodiment of the invention. TABLE 1 SCRIPT COMMANDS CommandDescription CLS: {LF} Clear the display. ZAP: {LF} Erase from memory thelast set of query responses recorded. LED: b{LF} Turn the LED on or off,where b is a binary digit of 0 or 1. An argument of 1 turns on the LED,and an argument of 0 turns off the LED. DISPLAY: Display the textfollowing the DISPLAY {chars} {LF} command. INPUT: mmmm{LF} Record abutton press. The m's represent a button mask pattern for each of thefour input buttons. Each m contains an “X” for disallowed buttons or an“O” for allowed buttons. For example, INPUT: OXOX{LF} allows the user topress either button #1 or #3. WAIT: {LF} Wait for any one button to bepressed, then continue executing the script program. COLLECT: Collectmeasurements from the monitoring device{LF} device specified in theCOLLECT command. The user is preferably prompted to connect thespecified monitoring device to the apparatus and press a button tocontinue. NUMBER: aaaa{LF} Assign a script identification code to thescript program. The script identification code from the most recentlyexecuted NUMBER statement is subsequently transmitted to the serveralong with the query responses and device measurements. The script iden-tification code identifies to the server which script program was mostrecently executed by the remote apparatus. DELAY: t {LF} Wait until timet specified in the DELAY command, usually the prescribed connectiontime. CONNECT: {LF} Perform a connection routine to establish acommunication link to the server, transmit the patient identificationcode, query responses, device measurements, and script identificationcode to the server, and receive and store a new script pro- gram. Whenthe server instructs the apparatus to disconnect, the script interpreteris restarted, allowing the new script program to execute.

The script commands illustrated in Table 1 are representative of thepreferred embodiment and are not intended to limit the scope of theinvention. After consideration of the ensuing description, it will beapparent to one skilled in the art many other suitable scriptinglanguages and sets of script commands may be used to implement theinvention.

Script generator 2050 preferably stores a script program template whichit uses to create each script program. To generate a script program,script generator 2050 inserts into the template the script informationentered in screen 2056. For example, FIGS. 17A-17B illustrate a samplescript program created by script generator 2050 from the scriptinformation shown in FIG. 16.

The script program includes display commands to display the queries andresponse choices entered in fields 2094 and 2096, respectively. Thescript program also includes input commands to receive responses to thequeries. The script program further includes a collect command tocollect device measurements from the monitoring device specified incheck boxes 2098. The script program also includes commands to establisha subsequent communication link to the server at the connection timespecified in field 2100. The steps included in the script program arealso shown in the flow chart of FIGS. 23A-23B and will be discussed inthe operation section below.

Referring again to FIG. 13, script assignor 2052 is for assigning scriptprograms 2040 to the patients. Script programs 2040 are assigned inaccordance with script assignment information entered throughworkstation 2020. The script assignment information is entered through ascript assignment screen 2057, which is preferably implemented as a webpage on server 2018.

FIG. 18 illustrates a sample script assignment screen 2057 as it appearson workstation 2020. Screen 2057 includes check boxes 2106 for selectinga script program to be assigned and check boxes 2108 for selecting thepatients to whom the script program is to be assigned. Screen 2057 alsoincludes an ASSIGN SCRIPT button 2112 for entering the assignments. Whenbutton 2112 is pressed, the script assignor creates and stores for eachpatient selected in check boxes 2108 a respective pointer to the scriptprogram selected in check boxes 2106. Each pointer is stored in thepatient look-up table of the database. Screen 2057 further includes anADD SCRIPT button 2110 for accessing the script entry screen and aDELETE SCRIPT button 2114 for deleting a script program.

Referring again to FIG. 13, report generator 2054 is designed togenerate a patient report 2058 from the responses and devicemeasurements received in server 2018. Patient report 2058 is displayedon workstation 2020. FIG. 21 shows a sample patient report 2058 producedby report generator 2054 for a selected patient. Patient report 2058includes a graph 2116 of the device measurements received from thepatient, as well as a listing of responses 2042 received from thepatient. Specific techniques for writing a report generator program todisplay data in this manner are well known in the art.

The operation of the preferred embodiment is illustrated in FIGS. 12-23.FIG. 22A is a flow chart illustrating steps included in the monitoringapplication executed by server 2018. FIG. 22B is a continuation of theflow chart of FIG. 22A. In step 2202, server 2018 determines if newscript information has been entered through script entry screen 2056. Ifnew script information has not been entered, server 2018 proceeds tostep 2206. If new script information has been entered, server 2018proceeds to step 2204.

As shown in FIG. 16, the script information includes a set of queries,and for each of the queries, corresponding responses choices. The scriptinformation also includes a selected monitoring device type from whichto collect device measurements. The script information further includesa prescribed connection time for each apparatus to establish asubsequent communication link to the server. The script information isgenerally entered in server 2018 by a healthcare provider, such as thepatients' physician or case manager. Of course, any person desiring tocommunicate with the patients may also be granted access to server 2018to create and assign script programs. Further, it is to be understoodthat the system may include any number of remote interfaces for enteringscript generation and script assignment information in server 2018.

In step 2204, script generator 2050 generates a script program from theinformation entered in screen 2056. The script program is stored indatabase 2038. Steps 2202 and 2204 are preferably repeated to generatemultiple script programs, e.g. a script program for diabetes patients, ascript program for asthma patients, etc. Each script program correspondsto a respective one of the sets of queries entered through script entryscreen 2056. Following step 2204, server 2018 proceeds to step 2206.

In step 2206, server 2018 determines if new script assignmentinformation has been entered through assignment screen 2057. If newscript assignment information has not been entered, server 2018 proceedsto step 2210. If new script assignment information has been entered,server 2018 proceeds to step 2208. As shown in FIG. 18, the scriptprograms are assigned to each patient by selecting a script programthrough check boxes 2106, selecting the patients to whom the selectedscript program is to be assigned through check boxes 2108, and pressingthe ASSIGN SCRIPT button 2112. When button 2112 is pressed, scriptassignor 2052 creates for each patient selected in check boxes 2108 arespective pointer to the script program selected in check boxes 2106.In step 2208, each pointer is stored in look-up table 2046 of database2038. Following step 2208, server 2018 proceeds to step 2210.

In step 2210, server 2018 determines if any of the apparatuses areremotely connected to the server. Each patient to be monitored ispreferably provided with his or her own apparatus which has thepatient's unique identification code stored therein. Each patient isthus uniquely associated with a respective one of the apparatuses. Ifnone of the apparatuses is connected, server 02018 proceeds to step2220.

If an apparatus is connected, server 2018 receives from the apparatusthe patient's unique identification code in step 2212. In step 2214,server 2018 receives from the apparatus the query responses 2042, devicemeasurements 2044, and script identification code recorded duringexecution of a previously assigned script program. The scriptidentification code identifies to the server which script program wasexecuted by the apparatus to record the query responses and devicemeasurements. The responses, device measurements, and scriptidentification code are stored in database 2038.

In step 2216, server 2018 uses the patient identification code toretrieve from table 2046 the pointer to the script program assigned tothe patient. The server then retrieves the assigned script program fromdatabase 2038. In step 2218, server 2018 transmits the assigned scriptprogram to the patient's apparatus through communication network 2024.Following step 2218, server 2018 proceeds to step 2220.

In step 2220, server 2018 determines if a patient report request hasbeen received from workstation 2020. If no report request has beenreceived, server 2018 returns to step 2202. If a report request has beenreceived for a selected patient, server 2018 retrieves from database2038 the measurements and query responses last received from thepatient, step 2222. In step 2224, server 2018 generates and displayspatient report 2058 on workstation 2020. As shown in FIG. 21, report2058 includes the device measurements and query responses last receivedfrom the patient. Following step 2224, the server returns to step 2202.

FIGS. 23A-23B illustrate the steps included in the script programexecuted by apparatus 2026. Before the script program is received,apparatus 2026 is initially programmed with the patient's uniqueidentification code and the script interpreter used by microprocessor2076 to execute the script program. The initial programming may beachieved during manufacture or during an initial connection to server2018. Following initial programming, apparatus 2026 receives from server2018 the script program assigned to the patient associated withapparatus 2026. The script program is received by modem 2086 through afirst communication link and stored in memory 2080.

In step 2302, microprocessor 2076 assigns a script identification codeto the script program and stores the script identification code inmemory 2080. The script identification code is subsequently transmittedto the server along with the query responses and device measurements toidentify to the server which script program was most recently executedby the apparatus. In step 2304, microprocessor 2076 lights LED 2074 tonotify the patient that he or she has unanswered queries stored inapparatus 2026. LED 2074 preferably remains lit until the queries areanswered by the patient. In step 2306, microprocessor 2076 erases frommemory 2080 the last set of query responses recorded.

In step 2308, microprocessor 2076 prompts the patient by displaying ondisplay 2064 “ANSWER QUERIES NOW? PRESS ANY BUTTON TO START”. In step2310, microprocessor 2076 waits until, a reply to the prompt is receivedfrom the patient. When a reply is received, microprocessor 2076 proceedsto step 2312. In step 2312, microprocessor 2076 executes successivedisplay and input commands to display the queries and response choiceson display 2064 and to receive responses to the queries.

FIG. 19 illustrates a sample query and its corresponding responsechoices as they appear on display 2064. The response choices arepositioned on display 2064 such that each response choice is locatedproximate a respective one of the input buttons. In the preferredembodiment, each response choice is displayed immediately above arespective input button. The patient presses the button corresponding tohis or her response. Microprocessor 2076 stores each response in memory2080.

In steps 2314-2318, microprocessor 2076 executes commands to collectdevice measurements from a selected monitoring device. The scriptprogram specifies the selected monitoring device from which to collectthe measurements. In step 2314, microprocessor 2076 prompts the patientto connect the selected monitoring device, for example a blood glucosemeter, to one of the device jacks. A sample prompt is shown in FIG. 20.In step 2316, microprocessor 2076 waits until a reply to the prompt isreceived from the patient. When a reply is received, microprocessor 2076proceeds to step 2318. Microprocessor 2076 also connects UART 2078 tointerface 2090 through switch 2088. In step 2318, microprocessor 2076collects the device measurements from monitoring device 2028 throughinterface 2090. The measurements are stored in memory 2080.

In step 2320, microprocessor 2076 prompts the patient to connectapparatus 2026 to telephone jack 2022 so that apparatus 2026 may connectto server 2018 at the prescribed connection time. In step 2322,microprocessor 2076 waits until a reply to the prompt is received fromthe patient. When a reply is received, microprocessor 2076 turns off LED2074 in step 2324. In step 2326, microprocessor 2076 waits until it istime to connect to server 2018. Microprocessor 2076 compares theconnection time specified in the script program to the current timeoutput by clock 2084. When it is time to connect, microprocessor 2076connects UART 2078 to modem 2086 through switch 2088.

In step 2328, microprocessor 2076 establishes a subsequent communicationlink between apparatus 2026 and server 2018 through modem 2086 andcommunication network 2024. If the connection fails for any reason,microprocessor 2076 repeats step 2328 to get a successful connection. Instep 2330, microprocessor 2076 transmits the device measurements, queryresponses, script identification code, and patient identification codestored in memory 2080 to server 2018 through the subsequentcommunication link. In step 2332, microprocessor 2076 receives throughmodem 2086 a new script program from server 2018. The new script programis stored in memory 2080 for subsequent execution by microprocessor2076. Following step 2332, the script program ends.

One advantage of the monitoring system of the present invention is thatit allows each patient to select a convenient time to respond to thequeries, so that the monitoring system is not intrusive to the patient'sschedule. A second advantage of the monitoring system is that it incursvery low communications charges because each remote apparatus connectsto the server at times when communication rates are lowest. Moreover,the cost to manufacture each remote apparatus is very low compared topersonal computers or internet terminals, so that the monitoring systemis highly affordable.

A third advantage of the monitoring system is that it allows eachapparatus to be programmed remotely through script programs. Patientsurveys, connection times, display prompts, selected monitoring devices,patient customization, and other operational details of each apparatusmay be easily changed by transmitting a new script program to theapparatus. Moreover, each script program may be easily created andassigned by remotely accessing the server through the Internet. Thus,the invention provides a powerful, convenient, and inexpensive systemfor remotely monitoring a large number of patients.

FIGS. 24-26 illustrate a second embodiment of the invention in whicheach remotely programmable apparatus has speech recognition and speechsynthesis functionality. FIG. 24 shows a perspective view of anapparatus 2027 according to the second embodiment. Apparatus 2027includes a speaker 2072 for audibly communicating queries and prompts tothe patient. Apparatus 2027 also includes a microphone 2118 forreceiving spoken responses to the queries and prompts. Apparatus 2027may optionally include a display 2064 for displaying prompts to thepatient, as shown in FIG. 25.

FIG. 26 is a schematic block diagram illustrating the components ofapparatus 2027 in greater detail. Apparatus 2027 is similar in design tothe apparatus of the preferred embodiment except that apparatus 2027includes an audio processor chip 2120 in place of microprocessor 2076.Audio processor chip 2120 is preferably an RSC-164 chip commerciallyavailable from Sensory Circuits Inc. of 1735 N. First Street, San Jose,Calif. 95112.

Audio processor chip 2120 has a microcontroller 2122 for executingscript programs received from the server. A memory 2080 is connected tomicrocontroller 2122. Memory 2080 stores the script programs and ascript interpreter used by microcontroller 2122 to execute the scriptprograms. Memory 2080 also stores measurements received from monitoringdevice 2028, responses to the queries, script identification codes, andthe patient's unique identification code.

Audio processor chip 2120 also has built in speech synthesisfunctionality for synthesizing queries and prompts to a patient throughspeaker 2072. For speech synthesis, chip 2120 includes a digital toanalog converter (DAC) 2142 and an amplifier 2144. DAC 2142 andamplifier 2144 drive speaker 2072 under the control of microcontroller2122.

Audio processor chip 2120 further has built in speech recognitionfunctionality for recognizing responses spoken into microphone 2118.Audio signals received through microphone 2118 are converted toelectrical signals and sent to a preamp and gain control circuit 2128.Preamp and gain control circuit 2128 is controlled by an automatic gaincontrol circuit 2136, which is in turn controlled by microcontroller2122. After being amplified by preamp 2128, the electrical signals enterchip 2120 and pass through a multiplexer 2130 and an analog to digitalconverter (ADC) 2132. The resulting digital signals pass through adigital logic circuit 2134 and enter microcontroller 2122 for speechrecognition.

Audio processor chip 2120 also includes a RAM 2138 for short term memorystorage and a ROM 2140 which stores programs executed by microcontroller2122 to perform speech recognition and speech synthesis. Chip 2120operates at a clock speed determined by a crystal 2126. Chip 2120 alsoincludes a clock 2084 which provides the current date and time tomicrocontroller 2122. As in the preferred embodiment, apparatus 2027includes an LED 2074, display driver 2082, modem 2086, and deviceinterface 2090, all of which are connected to microcontroller 2122.

The operation of the second embodiment is similar to the operation ofthe preferred embodiment except that queries, response choices, andprompts are audibly communicated to the patient through speaker 2072rather than being displayed to the patient on display 2064. Theoperation of the second embodiments also differs from the operation ofthe preferred embodiment in that responses to the queries and promptsare received through microphone 2118 rather than through user inputbuttons.

The script programs of the second embodiment are similar to the scriptprogram shown in FIGS. 17A-17B, except that each display command isreplaced by a speech synthesis command and each input command isreplaced by a speech recognition command. Referring to FIG. 26, thespeech synthesis commands are executed by microcontroller 2122 tosynthesize the queries, response choices, and prompts through speaker2072. The speech recognition commands are executed by microcontroller2122 to recognize responses spoken into microphone 2118.

For example, to ask the patient how he or she feels and record aresponse, microcontroller 2122 first executes a speech synthesis commandto synthesize through speaker 2072 “How do you feel? Please answer withone of the following responses: very bad, bad, good, or very good.”Next, microcontroller 2122 executes a speech recognition command torecognize the response spoken into microphone 2118. The recognizedresponse is stored in memory 2080 and subsequently transmitted to theserver. Other than the differences described, the operation andadvantages of the second embodiment are the same as the operation andadvantages of the preferred embodiment described above.

Although the first and second embodiments focus on querying individualsand collecting responses to the queries, the system of the invention isnot limited to querying applications. The system may also be used simplyto communicate messages to the individuals. FIGS. 27-30 illustrate athird embodiment in which the system is used to perform this automatedmessaging function. In the third embodiment, each script programcontains a set of statements to be communicated to an individual ratherthan a set of queries to be answered by the individual. Of course, itwill be apparent to one skilled in the art that the script programs mayoptionally include both queries and statements.

The third embodiment also shows how the queries and statements may becustomized to each individual by merging personal data with the scriptprograms, much like a standard mail merge application. Referring to FIG.27, personal data relating to each individual is preferably stored inlook-up table 2046 of database 2038. By way of example, the data mayinclude each individual's name, the name of each individual's physician,test results, appointment dates, or any other desired data. As in thepreferred embodiment, database 2038 also stores generic script programs2040 created by script generator 2050.

Server 2018 includes a data merge program 2055 for merging the datastored in table 2046 with generic script programs 2040. Data mergeprogram 2055 is designed to retrieve selected data from table 2046 andto insert the data into statements in generic script programs 2040, thuscreating custom script programs 2041. Each custom script program 2041contains statements which are customized to an individual. For example,the statements may be customized with the individual's name, testresults, etc. Examples of such customized statements are shown in FIGS.28-29.

The operation of the third embodiment is similar to the operation of thepreferred embodiment except that the script programs are used tocommunicate messages to the individuals rather than to query theindividuals. Each message is preferably a set of statements. Referringto FIG. 30, the statements may be entered in the server through scriptentry screen 2056, just like the queries of the preferred embodiment.

Each statement preferably includes one or more insert commandsspecifying data from table 2046 to be inserted into the statement. Theinsert commands instruct data merge program 2055 to retrieve thespecified data from database 2038 and to insert the data into thestatement. For example, the insert commands shown in FIG. 30 instructthe data merge program to insert a physician name, an appointment date,a patient name, and a test result into the statements. As in thepreferred embodiment, each statement may also include one or moreresponse choices which are entered in fields 2096.

Following entry of the statements and response choices, CREATE SCRIPTbutton 2102 is pressed. When button 2102 is pressed, script generator2050 generates a generic script program from the information entered inscreen 2056. The generic script program is similar to the script programshown in FIGS. 17A-17B, except that the display commands specifystatements to be displayed rather than queries. Further, the statementsinclude insert commands specifying data to be inserted into the scriptprogram. As in the preferred embodiment, multiple script programs arepreferably generated, e.g. a generic script program for diabetespatients, a generic script program for asthma patients, etc. The genericscript programs are stored in database 2038.

Following generation of the generic script programs, server 2018receives script assignment information entered through script assignmentscreen 2057. As shown in FIG. 18, the script programs are assigned byfirst selecting one of the generic script programs through check boxes2106, selecting individuals through check boxes 2108, and pressing theASSIGN SCRIPT button 2112. When button 2112 is pressed, data mergeprogram 2055 creates a custom script program for each individualselected in check boxes 2108.

Each custom script program is preferably created by using the selectedgeneric script program as a template. For each individual selected, datamerge program 2055 retrieves from database 2038 the data specified inthe insert commands. Next, data merge program 2055 inserts the data intothe appropriate statements in the generic script program to create acustom script program for the individual. Each custom script program isstored in database 2038.

As each custom script program is generated for an individual, scriptassignor 2052 assigns the script program to the individual. This ispreferably accomplished by creating a pointer to the custom scriptprogram and storing the pointer with the individual's uniqueidentification code in table 2046. When the individual's remoteapparatus connects to server 2018, server 2018 receives from theapparatus the individual's unique identification code. Server 2018 usesthe unique identification code to retrieve from table 2046 the pointerto the custom script program assigned to the individual. Next, server2018 retrieves the assigned script program from database 2038 andtransmits the script program to the individual's apparatus throughcommunication network 2024.

The apparatus receives and executes the script program. The execution ofthe script program is similar to the execution described in thepreferred embodiment, except that statements are displayed to theindividual rather than queries. FIGS. 28-29 illustrate two samplestatements as they appear on display 2064. Each statement includes aresponse choice, preferably an acknowledgment such as “OK”. Afterreading a statement, the individual presses the button corresponding tothe response choice to proceed to the next statement. Alternatively, thescript program may specify a period of time that each statement is to bedisplayed before proceeding to the next statement. The remainingoperation of the third embodiment is analogous to the operation of thepreferred embodiment described above.

Although it is presently preferred to generate a custom script programfor each individual as soon as script assignment information is receivedfor the individual, it is also possible to wait until the individual'sapparatus connects to the server before generating the custom scriptprogram. This is accomplished by creating and storing a pointer to thegeneric script program assigned to the individual, as previouslydescribed in the preferred embodiment. When the individual's apparatusconnects to the server, data merge program 2055 creates a custom scriptprogram for the individual from the generic script program assigned tothe individual. The custom script program is then sent to theindividual's apparatus for execution.

Synopsis of the Detailed Description

FIGS. 31 and 32 provide a synopsis of the system and method of theinvention that is described above. FIG. 31 illustrates a Health CareProvider (HCP) apparatus 310, comprising a HCP Interaction Unit 312 thatis connected through a patient communication network 314 to a HCP DataManagement Unit 316. In the detailed description above, the HCPInteraction Unit 312 is variously described as a doctor's fax 55 (FIG.2), a doctor's computer 62 (FIG. 2), or a workstation 2020 (FIG. 12),which may be a personal computer, remote terminal, or web TV unit. TheHCP Data Management Unit 316 is alternatively described above as aclearinghouse 54 (FIGS. 1-2) or a server 2018 (FIG. 12), which isdescribed as a stand-alone personal computer or a network of computers.The patient communication network 312 is variously referred to above asthe communication network 2024 (preferably the Internet) (FIG. 12), atelephone line 64, or a second telephone line 68. As would be apparentto one skilled in the art, the patient communication network 312 mayalso simply be a wire or a cable. The Health Care Provider Apparatus 310is coupled to a communication network 318, which is described above as atelephone line 50 and modem 52 or as communication network 2024,preferably the Internet.

In FIG. 32, the Remotely Programmable Patient Apparatus 320 comprises aPatient Interaction Unit 322, which is connected through a patientcommunication network 324 to a Patient Data Management. Unit 326. In thedetailed description above, the Remotely Programmable Patient Apparatus320 is sometimes referred to as an individual self-care healthmonitoring system 58 (FIG. 2). The Patient Interaction Unit 322 isvariously described as handheld microprocessor unit 12 (FIG. 1), acommercially available compact video game system (such as the systemmanufactured by Nintendo of America Inc. under the trademark “GAME BOY”)(see e.g., FIG. 1), a game console 102 (FIG. 11), a palm-top computer,or a remote apparatus 2026, 2032 (FIGS. 12 and 14). The Patient DataManagement Unit 326 is alternatively described above as being a part ofthe remote apparatus 2026, 2032 (FIGS. 12 and 14) or as being a separatedata management unit 10 (FIG. 1). The patient communication network 324is sometimes referred to above as a cable 14 and may also be a wire orother signal communication medium, as would be apparent to those skilledin the art. The Remotely Programmable Patient Apparatus 320 is alsocoupled to the communication network 318. The patient monitoring device328 illustrated in FIG. 32 is variously referred to above as the bloodglucose monitor 16, peak flow meter 20, additional monitor 22 (FIG. 1),or monitoring device 2028 (FIG. 12).

The preceding synopsis is intended only to provide a summary overview ofthe present invention as described above and is not intended toreiterate all the functional equivalents for the components of theHealth Care Provider Apparatus 310 and the Remotely Programmable PatientApparatus 320 which have been described above or to describe thosefunctional equivalents that would be apparent to one skilled in the art.

Summary, Ramifications, and Scope

Although the above description contains many specificities, these shouldnot be construed as limitations on the scope of the invention but merelyas illustrations of some of the presently preferred embodiments. Manyother embodiments of the invention are possible. For example, thescripting language and script commands shown are representative of thepreferred embodiment. It will be apparent to one skilled in the art manyother scripting languages and specific script commands may be used toimplement the invention.

Moreover, the invention is not limited to the specific applicationsdescribed. The system and method of the invention have many otherapplication both inside and outside the healthcare industry. Forexample, pharmaceutical manufacturers may apply the system in theclinical development and post marketing surveillance of new drugs, usingthe system as an interactive, on-line monitoring tool for collectingdata on the efficacy, side effects, and quality of life impact of thedrugs. Compared to the current use of labor intensive patientinterviews, the system provides a fast, flexible, and cost effectivealternative for monitoring the use and effects of the drugs.

The system may also be used by home healthcare companies to enhance theservice levels provided to customers, e.g. panic systems, sleepsurveillance, specific monitoring of disease conditions, etc.Alternatively, the system may be used to monitor and optimize theinventory of home stationed health supplies. As an example, the systemmay be connected to an appropriate measuring device to optimize timingof oxygen tank delivery to patients with COPD.

The system and method of the invention also have many applicationsoutside the healthcare industry. For example, the system may be used forremote education over the Internet, facilitating educationalcommunication with children or adult trainees who lack access tosophisticated and expensive computer equipment. The system may also beused by law enforcement officers to perform on-line surveillance ofindividuals on probation or parole.

Further, the invention has numerous applications for gathering data fromremotely located devices. For example, the system may be used to collectdata from smart appliances, such as identification check systems.Alternatively, the system may be applied to the remote monitoring offacilities, including safety and security monitoring, or toenvironmental monitoring, including pollution control and pipelinemonitoring. Many other suitable applications of the invention will beapparent to one skilled in the art.

1. A method for the remote monitoring and management of a patient'shealth condition by a health care provider, the method comprising: a)providing a health care provider apparatus to the health care provider,the health care provider apparatus, comprising: i). a health careprovider interaction unit having: A). a health care provider interactionunit display that is controlled by a health care provider interactionunit interface, the health care provider interaction unit interfaceaccepting a health care provider display information and rendering thehealth care provider display information for display on the health careprovider interaction unit display; B). a health care providerinteraction unit input device that receives a health care provider inputform the health care provider, the health care provider interaction unitinput device sending the health care provider input to the health careprovider interaction interface; ii). a health care provider datamanagement unit, comprising: A). a health care provider centralprocessing unit having a health care provider script program; B). ahealth care provider communication circuit coupled to the health careprovider central processing unit; C). a health care provider memorycoupled to the health care provider central processing unit; b).generating the script program with the health care provider scriptgenerator, the script program having script commands representing acomputer-executable patient protocol for the management and monitoringof the patient's health condition; c). providing a remotely-programmablepatient apparatus to the patient, the remotely-programmable patientapparatus, comprising: i). a patient interaction unit having: A). apatient interaction unit display that is controlled by a patientinteraction unit interface, the patient interaction unit interfaceaccepting a patient display information and rendering the patientdisplay information for display on the patient interaction unit display;B). a patient interaction unit input device that receives a patient datafrom the patient, the patient interaction unit input device sending thepatient data to the patient interaction unit interface; ii). a patientdata management unit, comprising: A). a patient central processing unithaving a patient script processor for processing the script program; B).a patient communication circuit coupled to the patient centralprocessing unit; C). a patient memory coupled to the patient centralprocessing unit; d). connecting the health care provider apparatus tothe communication network by way of the health care providercommunication means; e). connecting the remotely programmable patientapparatus to the communication network by way of the patentcommunication means; f). downloading the script program from the healthcare provider apparatus to the remotely programmable patient apparatusover the communication network; g). processing the script program withthe patient central processing means of the remotely programmablepatient apparatus, the processing of the script program producing thepatient display information; h). displaying the patient displayinformation to the patient on the patient interaction unit display ofthe patient interaction unit. 2-53. (canceled)
 54. A medical device formonitoring and managing one or more ambulatory patients on a computerand allowing a caregiver to review the ambulatory patients' wellnessparameters to provide treatment in accordance with the wellnessparameters, the medical device comprising: a processing unit; acomputer-readable medium associated with the processing unit; a sensor,operably coupled with the processing unit, the sensor detecting at leastone physiological parameter of the patient; an output device, operablycoupled with the processing unit, the output device prompting thepatient with at least one question; an input device, operably coupledwith the processing unit, the input device permitting the patient torespond to the at least one question; a communication device operablycoupled to the processing unit; wherein the computer-readable medium isprogrammed with a set of instructions that cause the processing unit tocooperate with the communication device to automatically initiate afirst communication session at a specified time of day, wherein duringthe first communication session at least one question is received from aremote computer; prompt the patient with the at least one question viathe output device; receive at least one response to the at least onequestion via the input device; and transmit the at least one responseand the at least one physiological parameter to the remote computer viathe communication device.
 55. The medical system of claim 54, whereinthe computer-readable medium is further programmed with a set ofinstructions that cause the processing unit to: receive from the remotecomputer at least one question to be used for prompting the patientafter the first communication session has been terminated; and transmitto the remote computer at least one response entered by the patientprior to the initiation of the first communication session.
 56. Themedical system of claim 54, wherein the computer-readable medium isfurther programmed with a set of instructions that cause the processingunit to: prompt the patient with the at least one question after thefirst communication session has been terminated; measure at least onephysiological parameter of the patient; acquire at least one response tothe at least one question; and initiate a second communication sessionwith the central computer, during which the processing unit transmits tothe central computer the at least one physiological parameter and the atleast one response.
 57. The medical system of claim 54, wherein thesecond communication session is initiated at the command of the patient.58. A medical device for monitoring and managing one or more self-carepatients on a computer and enabling a health care provider to review theself-care patients' health parameters to provide treatment in accordancewith the health parameters, the medical device comprising: a processor;a computer-readable memory associated with the processor; a sensor,operably interconnected with the processor, the sensor taking at leastone measurement of a physiological health indicator of the patient; anoutput device, operably interconnected with the processor, the outputdevice prompting the patient with at least one query; an input device,operably interconnected with the processor, the input device permittingthe patient to respond to the at least one query; a communication deviceoperably interconnected to the processor; wherein the computer-readablememory is programmed with instructions that cause the processor tocooperate with the communication device to automatically initiate afirst communication session at a prescribed connection time, whereinduring the first communication session at least one query is receivedfrom a remote computer; prompt the patient with the at least one queryvia the output device; receive at least one response to the at least onequery via the input device; and transmit the at least one response andthe at least one physiological health indicator to the remote computervia the communication device.
 59. The medical device of claim 58,wherein the computer-readable memory stores programs that cause theprocessor to: receive from the remote computer at least one question tobe used for prompting the patient after the first communication sessionhas been terminated; and transmit to the remote computer at least oneresponse entered by the patient prior to initiation of the firstcommunication session.
 60. The medical device of claim 58, wherein thecomputer-readable memory is further stores programs that cause theprocessor to: prompt the patient with at least one query after the firstcommunication session has been terminated; measure at least onephysiological health indicator of the patient; collect at least oneanswer to the at least one question; and initiate a second communicationsession with the remote computer, during which the processor transmitsto the remote computer the at least one physiological health indicatorand the at least one question.
 61. The medical device of claim 60,wherein the second communication session is initiated by the patient.